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Radiology Devices

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MI, MN, MS,MO, NT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, POLAND, PAKISTAN, NOWAY, NIGERIA, NETHERLANDS, MEXICO, MALAYSIA, LITHUANIA, LATVIA, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, ECUADOR, DOMINICA REPUBLIC, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BRAZIL BELGIUM, AUSTRIA, AUSTRALIA.

GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 || Advantage Sim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph

Mfg Lot or Serial # System ID 00000098016HL9 419291DR1 00000098927HL7 954MCHM656 00000099011HL9 513MWDR2 00000099012HL7 419PERRYDR 00000099013HL5 252962ED1 00000099016HL8 419435DR 00000099440HL0 417347DPORT1 00000099441HL8 708684RAD3 00000099443HL4 708684RAD2 00000099444HL2 732840ER1 00000099445HL9 504349R8 00000099447HL5 608775XR6561 00000099448HL3 408259RMCED1 00000099846HL8 239424XR656 00000099848HL4 HSSE3D656 00000099850HL0 732840ER2 00000099851HL8 7737021555 00000100228HL6 802775RAD5 00000100230HL2 440816D656 00000100231HL0 910WAROBINSON2 00000100366HL4 334793SXR656 00000100368HL0 608775XR6563 00000100369HL8 509838RM1 00000100653HL5 303GVA656RM3 00000100654HL3 225658DR1 00000100655HL0 718240UCD 00000100658HL4 802775RAD1 00000100659HL2 610902XR656 00000101139HL4 843847TR3 00000101140HL2 765747XR656 00000101251HL7 724357ED1 00000101252HL5 281METHP656 00000101253HL3 206598UWEAST 00000101255HL8 919731XR656 00000101256HL6 518943D656 00000101257HL4 630208DR4 00000101258HL2 314768SMRM5 00000101259HL0 303GVA656RM1 00000101260HL8 949517RM3 00000101261HL6 239HPCXR1 00000101881HL1 708226XR656B 00000101882HL9 313745ER656 00000101883HL7 504349R4 00000102301HL9 804764ER2 00000102304HL3 225658DR2 00000102305HL0 509946XR656A 00000102306HL8 303GVA656RM2 00000102307HL6 248305D656RM2 00000102575HL8 770385DR1 00000102576HL6 830RHHRAD1 00000102851HL3 757736PWR1 00000102852HL1 914MSK656 00000102853HL9 504349POB1 00000103439HL6 303DHXR656 00000103441HL2 910417XR656 00000103669HL8 312996D656 00000103671HL4 801714RM2DR 00000103672HL2 504842IMR2 00000103959HL3 304429DIS656 00000103961HL9 701234XR656 00000104239HL9 979SJRHCRAD 00000104241HL5 517841XR656 00000104242HL3 808QMCER 00000104243HL1 713792XR3656 00000104709HL1 850505NH656 00000104711HL7 816234COPC2 00000104712HL5 XR249643 00000104713HL3 770382CER 00000104714HL1 406731MXR1 00000105160HL6 713792XR3656 00000105161HL4 419291DR2 00000105162HL2 414649XR656 00000105163HL0 314633SW 00000105165HL5 720UCHAOP2 00000105503HL7 MHXRAY1 00000105506HL0 713792XR4656 00000105507HL8 717791D656 00000106114HL2 516719ERDIG 00000106120HL9 757736RM4 00000106123HL3 936SLW656RM2 00000106124HL1 MHXRAY2 00000106673HL7 310680RM3 00000106674HL5 865541EDXR 00000106677HL8 217383EDXR2 00000106678HL6 269966XR656B 00000106968HL1 763795XR1 00000106970HL7 608258656D2 00000106974HL9 913345MDR1 00000106975HL6 808QMCRM2 00000106976HL4 830RHHRAD4 00000107176HL0 608258656D1 00000107177HL8 912920HXR656 00000107381HL6 314525656RM4 00000107383HL2 719VAMC123 00000107386HL5 217383EDXR1 00000107816HL1 915595XR656 00000107818HL7 734439XR656MAIN 00000107820HL3 412664R18 00000107821HL1 NYPAL222 00000108130HL6 DUKEURO656 00000108133HL0 815547D656 00000108134HL8 GWNT656XR1 00000108136HL3 646888XR656C 00000108703HL0 504842ORTH2 00000108709HL7 630208DER656 00000108714HL7 361694DR1 00000108722HL0 281METHSPXR 00000109569HL4 585922WILRADDR1 00000109570HL2 847570DR4 00000109987HL8 505UNMH656 00000110168HL2 646888XR656A 00000110173HL2 504873TR3D 00000110174HL0 646888XR656B 00000110428HL0 936SLW656RM1 00000110869HL5 908232D656 00000110870HL3 386FHD656 00000110877HL8 419529D656 00000103954HL4 707SSRD656 00000103956HL9 816234COPC3 00000104706HL7 254SWCHRAD1 00000105501HL1 269966XR656A 00000106125HL8 217379PXR1 00000107376HL6 828298S 00000107812HL0 757953ORTH2 00000107813HL8 313576D656B 00000108693HL3 518243ER1 00000108696HL6 4164522 00000107388HL1 GON:4180565 00000108131HL4 GON:4191836 00000108411HL0 716821OPRM2 00000108705HL5 217586G656 00000108708HL9 GON:4212438 00000108721HL2 530332XR656TR 00000109567HL8 530332XR656 00000110167HL4 GON:4180557 00000110169HL0 719VAMC124 00000110170HL8 716821OPRM1 00000110175HL7 719VAMC125 00000110432HL2 530244XR656 00000110879HL4 706544XR 00000103667HL2 217784GXR 00000105158HL0 510HCPXR656 00000105159HL8 GON: 4046606 00000107374HL1 713792FP1XR4656 00000107378HL2 707432DR3 00000108700HL6 913541ODR1 00000111354HL7 GON:1628351 00000111355HL4 GON:1628351 00000104715HL8 GON:1587706 00000108701HL4 GON:1611990 00000108712HL1 GON:4207312 00000108718HL8 GON:4191887 00000108725HL3 GON:1622072 00000109563HL7 GON:4173819 00000109566HL0 GON:4112452 00000109986HL0 GON:1611995 00000109988HL6 GON:4166880 00000109992HL8 GON:130308027 00000111371HL1 GON:1628574 00000111356HL2 GON:131496980 00000111401HL6 GON:133368920 00000112358HL7 GON:1640581 00000110172HL4 GON:1436073 00000099847HL6 83095224789 00000100365HL6 83093200335 00000109154HL5 83095135282 00000109561HL1 GON:4164862 00000108716HL2 GON:4164862 00000109564HL5 GON:4164862 00000104669HL7 GON:1000224 00000102302HL7 030392RX05 00000101250HL9 210013RX41 00000102580HL8 210013RX44 00000108720HL4 GON:41100556 00000102303HL5 GON:4157378 00000102578HL2 GON:4151792 00000103438HL8 GON:4157379 00000106972HL3 GON:4175012 00000107180HL2 GON:4157382 00000107817HL9 GON:4157381 00000109993HL6 GON:4204596 00000103668HL0 GON:4038825 00000103955HL1 GON:4038787 00000103957HL7 GON:4161140 00000104704HL2 GON:4038827 00000105156HL4 GON:4038819 00000104708HL3 GON: 4139130 00000105157HL2 GON:4038817 00000106126HL6 GON:4038781 00000110164HL1 514637RAD1 00000106122HL5 XR1032629WK6 00000105505HL2 GON:1450286 00000099014HL3 082407040509 00000099015HL0 082407040501 00000099437HL6 082407050127 00000099438HL4 082407090176 00000099439HL2 082407040507 00000099442HL6 082407050126 00000099446HL7 082407050129 00000100364HL9 082407050125 00000100656HL8 082407270123 00000101254HL1 082407040531 00000102577HL4 082407120255 00000103670HL6 082407040518 00000103675HL5 082407040514 00000104710HL9 082407070182 00000105981HL5 082407040529 00000106115HL9 082407160363 00000106119HL1 082407180093 00000106675HL2 082407040536 00000107179HL4 082407070184 00000107182HL8 082407070185 00000108137HL1 082407080108 00000108407HL8 082407080110 00000108724HL6 082407040548 00000104707HL5 082407070183 00000108694HL1 082407040539 00000107384HL0 082407070185 00000108406HL0 082407130283 00000108408HL6 082407120266 00000108695HL8 082407040538 00000108410HL2 082407070181 00000108702HL2 082407120265 00000109562HL9 082407040547 00000109565HL2 082407100511 00000110166HL6 082407100509 00000101884HL5 DK1314RX01 00000104705HL9 FI1260RX01 00000103960HL1 A5485253 00000102579HL0 D4200415 00000104238HL1 510383XR01 00000104668HL9 PC0127XR07 00000111353HL9 TP3887XR01 00000110873HL7 GON :4190435 00000110425HL6 HU1906RX01 00000100229HL4 83007000033413 00000100362HL3 83007861012013 00000099459HL0 A224857304 00000103435HL4 A54013111 00000103436HL2 A5367405 00000099003HL6 A5198035 00000103958HL5 B5368906 00000099845HL0 WB0319 00000100367HL2 WB0322 00000104244HL9 WB0002 00000104717HL4 WB0321 00000105504HL5 WB0003 00000105980HL7 WB0004 00000106121HL7 WB0331 00000106672HL9 WB0325 00000106676HL0 WB0326 00000106969HL9 WB0330 00000106973HL1 WB0324 00000107178HL6 WB0323 00000107815HL3 WB0327 00000107822HL9 WB0148 00000108132HL2 WB0329 00000108135HL5 WB0005 00000108409HL4 WB0328 00000108723HL8 WB0334 00000107181HL0 WB0006 00000108704HL8 WB0332 00000099007HL7 850070872 00000111362HL0 850070883 00000109572HL8 0850070880 or 0850070881 00000110427HL2 0850070880 or 0850070881 00000108706HL3 KW1117RX02 00000108711HL3 KW1117RX04 00000099844HL3 KW1018RX13 00000107382HL4 GON:4154389 00000110878HL6 MA1521RX03 00000099010HL1 85092575331 00000105500HL3 85105688366 00000100657HL6 NO1049RX01 00000103440HL4 NO1009RX09 00000104240HL7 NO1154RX01 00000107380HL8 NO1049RX04 00000111359HL6 NO1049RX07 00000111363HL8 Unlocated 00000111381HL0 Unlocated 00000112379HL3 Unlocated 00000113283HL6 Unlocated 00000111369HL5 Unlocated 00000108710HL5 GON:4127780 00000109990HL2 GON:4127780 00000109991HL0 GON:4127780 00000110429HL8 GON: 4127780 00000100227HL8 RU1785RX03 00000098015HL1 SA1012RX20 00000104673HL9 SA2385RX01 00000104716HL6 SA2387RX02 00000104719HL0 SA2387RX01 00000106971HL5 SA2385RX02 00000108717HL0 SA2397RX01 00000110431HL4 GON 4168426 00000099005HL1 SA1058RX18 00000099460HL8 SA1058RX12 00000100363HL1 SA1058RX13 00000107375HL8 GON:4168540 00000107377HL4 SA2061RX03 00000108413HL6 SA2394RX01 00000108697HL4 SA2061RX02 00000104718HL2 GON:4136657 00000107814HL6 GON:4168547 00000108139HL7 SF712273040PA 00000110866HL1 GON:4168533 00000110171HL6 SA2079RX06 00000108412HL8 SI4059RX03 00000106116HL7 CEZ01500 00000106117HL5 CEZ01503 00000106118HL3 CEZ01506 00000107385HL7 CEZ01512 00000107387HL3 CEZ01509 00000107819HL5 CEZ01524 00000108129HL8 CEZ01521 00000108138HL9 DEN272116 00000108707HL1 CEZ01518 00000108715HL4 CEZ01515 00000103666HL4 W009RX01 00000110165HL8 A021RX01 00000110876HL0 856070122 00000110430HL6 GON :4186541 00000099843HL5 GON:4112121 00000099849HL2 GON: 4121735 00000100232HL8 00681RAD09 00000103673HL0 00681RAD08 00000103674HL8 IE1564RX04 00000105164HL8 00529RAD05 00000105502HL9 00440RAD30 00000108405HL2 00529RAD06 00000108719HL6 10692RAD01 00000109568HL6 00490RAD10 00000109571HL0 00490RAD11 00000100233HL6 XR1031601WK6

Orthopedic Devices

USA: AL, CA, CO, FL, GA, HI, IL, IN, KS, LA, MD,MI, MN, MO, MT, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, RUSSIA, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN,THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.

GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.

Physical Medicine Devices

1

No

Nationwide Distribution including Guam, DC, and Puerto Rico. OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL SALVADOR, SRILANKA, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, NEW ZEALAND, NICARAGUA, NEPAL, MYANMAR, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LEBANON, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HON GONG, GERMANY, FRANCE, FINLAND, ETHIOPIA, EGYPT, ECUADOR, DOMINICAN REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE , CAYMAN ISLAND , CANADA, CAMBODIA, BRUNEI DARUSSALAM, BRAZIL, BOLIVIA, BHUTAN, BANGLADESH, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.

GE Healthcare, Treadmill T2100. || For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

See Attached Spreadsheat

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,

Giraffe Exam Light || The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the Giraffe OmniBed, incubators and warmers except for Panda and Giraffe Warmers. It is not intended for use to support surgical field lighting.

Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444

General Hospital and Personal Use Devices

1

No

USA (nationwide)

Rotating IV Pole || Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.

Expiration for kit is four years.   Oz Masks  #D075986 Class I Exempt Device  If you have purchased directly from Vital Signs, the product codes affected are: 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2, Kits with masks included: 7730ALS, 7730BLU5, 7730FLY, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5. If you have purchased directly from Armstrong Medical, the Product Codes affected are: AE-4700 AE-4712, AE-4701, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, 7730GRN, 7700RAW, 7700PAW, 7700YAW, 7700WAW, 7700BAW, 7700OAW, 7700GAW " Lot numbers of the affected modules are: 2009 K109 through K365 2010 P001 through P149510 (k) : K781055; Medical Device Listing   Blood Pressure Cuffs  If you have purchased directly from Vital Signs, the product codes affected are: BP4030BR, BP4530BR, 7730POCH, 7730IALS If you have purchased directly from Armstrong Medical, the product codes affected are: AE-4703, AE- 4700, AE-4706, AE-4707 " Lot numbers affected are: For the year 2009 LOT Number 2689 through LOT Number 3659 For the year 2010 LOT Number 0010 through LOT Number 2530 Any lot number that ends in the number 1 is NOT affected by the recall.

Anesthesiology Devices

1

No

IL

Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA || The kit contains oxygen masks and blood pressure cuffs use on pediatric patients

Medical Device Listing number D110120.  5020AEHM 11087A  11098B 5701 5301C  5344E  5348V  5353K  5366T 5701E 5346Z 5702 5301D A0F52014 11091A  11098B A4112X14 11070A A415112A 11098B A41X2X24 11092A A4612X2C 11077A  11081B  11095B  11098A A4F12014 11075A  11084B  11090B  11091A  11094A  11101B  11091A  11101A A4F52X10 11075B  11077B  11082A  11090A A4F52X14 11074B A4U12214 11080B  11092A  11097A  11098A  11101A A4U52X1X 11083A  11087A  11090A A5152914 11077B  11080A A52X2314 11081A  11091A  11096B A5632X15 11070A  11095A A565192X 11094A  11095A  11095B  11096A  11097A A5U32020 11070A  11070B  11074B  11077B  11081A  11081B  11083A  11087A  11087B  11090A  11092A  11094B  11097A  11098A  11101A  11102A  11102B A5U32414 11077B  11080A  11082A  11082B  11090A  11094A  11094B  11097A  11097B  11098A A5U32X14 11076B  11083B  11084A A5U32X24 11070A  11077A  11080A  11083B  11087B  11098B  11101A  11102B A5U5201XX1 11076B  11083A  11088A  11090A  11101A A5W32014 11077A  11090B A5Z51914 11069B  11070A  11084A  11097B A8T52914 11082B A8U52015 11069A  11075A  11075B  11083B  11091A  11101B A8U5211X 11094A A8U52X14 11075A  11077A  11083A  11090B A8W52914 11069A  11083A  11088A  11094A A9U5211X 11080A  11090B  11094A AD132X14 11073A  11074A  11075A  11088A  11095B  11096B AD152914 11074B AD632X11 11070A  11073A  11074A  11081A  11083A ADA52014 11076A ADG5291X 11101B ADU12914 11074A  11074B  11075A  11087A  11090B  11094B  11098B  11101A  11101B ADU52914 11073A  11074A  11075A  11077A ADW32014 11073A  11083A  11087A  11094A  11098A  11098B  11101A AFN52024 11074A  11083B  11084A  11091B  11096A  11098B AFN5291C 11069B  11070B  11083A  11090A  11098A AFN52X1X 11070B  11088A AFR5191X 11069B AFR58014 11069B  11076A  11098B  11101A  11101B AFR5XX20 11073B  11101A AGN1QX1C 11070A  11070B  AGN5241C 11071A  11073A  11074B  11091A  11091B  11094A AIN52014 11070A  11074A  11075A  11076A  11082B  11083B  11087A  11087B  11090A  11095B  11101A AXXXX111 11075A  11098A AXXXXX83 11095B AXXXXX89 11095B B1154X14 11076A  11095A B1353X2X 11095A B1514X11 11073A  11098B B1534X15 11074B  11077B  11090A  11096A B1734X1Z 11069A  11091A B8734X24 11070A  11074A  11088A B9154X14 11073B  11098B G64X0XAX 11076B  11098A GABCXXXX 11087B  11088B  11094A  11096A GAK1OXXX 11076A  11076B  11083B  11084A  11084B  11087A  11087B  11088A  11095A  11095B  11096B  11097A GCEXXXXA 11082B  11087B  11097A  11098A GCRCKXXX 11070A  11091A GE9C0XAX 11083B  11101B GF1XXXAX 11070A  11084A  11088A  11088A  11101B GF7FOXGX 11069B  11083A  11083B GFJCXXXX 11084A  11102A GGYF0XAX 11080A  11098B GHAFXXXX 11080B  11082B  11087A  11088B  11094A  11094B  11094B  11095B  11098B GHBXXXXA 11070A  11070B  11075A  11087B  11091A  11095A GKXFXXAX 11073B  11080A  11094B GMAXXXJX 11094A  11098A  11098B GT1XXXJX 11070A GWKXXXGX 11074A  11083A  11090A  11098B GXXXXX67 11069B  11070A  11081A  11081B  11084B  11084B GXXXXX97 11073A  11101A GXXXXXX3 11087A  11094B

Anesthesiology Devices

1

No

Worldwide Distribution including the United States.

Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. || The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.

Definium Model 5000/5220493

Radiology Devices

1

No

Nationwide Distribution

GE Healthcare Definium 5000 / 5220493 X-Ray System

Definium Model 5000/5220493-2

Radiology Devices

1

No

Nationwide Distribution

GE Healthcare Definium 5000/5220493-2 X-Ray System

Model Number : 5271997

Radiology Devices

1

No

Nationwide Distribution including NM, WY, FL, MO, MA, and MI.

GE Healthcare Brivo XR385 DR-F/ X-Ray System || X-Ray System

Centricity Enterprise Archive versions: 4.0.x

Radiology Devices

1

No

Nationwide Distribution including AZ, OH, WA.

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).

Software versions: 3.0.x

Radiology Devices

1

No

US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.

The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols.

Version: 3.0.x

Radiology Devices

1

No

Nationwide Distribution

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).

Software Versions 3.3, 4.0, and 4.1

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England

The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact.

Software Versions: 3.3, 4.0, 4.1

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.

The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. || The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users

Versions 4.1, 4.0, 3.3.2 & 3.3Almp

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.

Centricity Laboratory Core Lab System 4.1 || The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.

Software Versions: 3.3, 4.0, 4.1

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US including MN and Internationally to India, Australia, Canada, and England.

The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. || The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users

Radiology Devices

1

No

Worldwide Distribution - US Nationwide, ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, VENEZUELA, VIETNAM, and YEMEN.

Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. || Kenex Suspension installed with Radiation shield and lamp with following model numbers: || E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. || Product Usage: || Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.

00000486566WK3, 00000486586WK1, 00000486555WK6, 00000486573WK9, 00000486581WK2, 00000478555WK6, 00000486579WK6, 00000486588WK7, 00000486557WK2, 00000486560WK6, 00000486550WK7, 00000486556WK4, 00000486547WK3, 00000056366VP8, 00000486544WK0, 00000486541WK6, 00000486543WK2, 00000471291WK5, 00000486568WK9, and 00000486559WK8

Radiology Devices

1

No

Worldwide Distribution --- USA including states of AZ, CA, FL, GA, IA, MD, MO, NC, NY, OH, OK, TN, TX,WI, and LA, and country of Slovak Republic.

Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems. || General-purpose radiographic system component used to suspend the system's image monitor.

This correction pertains to Uni-Circuits from lot# 084812 and later, up to and including lot# 092210

Anesthesiology Devices

1

No

Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.

GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780, || M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662, || M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255 || M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628, || M1145406, M1147298, M1137811, M1152651, M1160275. pkg of 20 pcs, Latex Free. Breathing circuit for use with anesthesia machine or ventilator.

All versions and releases

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: California, Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee and Texas, and internationally to Australia, Canada, China, England, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.

GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.

Software Version 3.3 and newer.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, including states of Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee, and Texas and countries of Australia, Canada, England, India, New Zealand, Qatar, and Scotland.

GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.

Physical Medicine Devices

1

No

CONTINENTAL USA DISTRIBUTION INCLUDING DC AND PR. OUS: ARGENTINA AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BHUTAN, BOLIVIA, BRAZIL, BRUNEI, CAMBODIA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, SPAIN, FINLAND, FRANCE, UNITED KIGDOM, GERMANY, GUAM, GUYANA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITLAY, JAMAICA, JAPAN, REPUBLIC OF KOREA, MACAU, MALYAYSIA, MARTINIQUE, MEXICO, MONACO, MYANMAR, NEPAL, NEW ZEALANAD, NICARAGUA, PANAMA, PARAGUAY, PERU, PHILIPPINES, PORTUGAL, RUSSIA. SINGAPORE, SOUTH KOREA, SRILANKA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, URUGUAY, UZBEKISTAN, VENEZUELA, VIET NAM.

GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. || UPDATE: 3-30-2015: || T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 || Product Usage: || Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

Software versions 3.x and 4.x

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, including AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, NC, NH, NJ, NY, OR, TN, VA, and WI, , and internationally to the countries of Australia, England, Hong Kong, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.

GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. || The Centricity Laboratory software is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results.

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Radiology Devices

1

No

Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY.

Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.