Alpha Pinnacle 10kVA UPS with External BaAlpha Pinnacle 10kVA UPS with External Battery Pack (EBP)

MD: Needle Guide; Needle Guide Starter Kit; Biopsy Starter Kit;

Verathon: BladderScan® BVI 9600 and AortaScan ®

Model Number: BVI 9600 a AMI 9700 Serial Number: všechna výrobní čísla

Medical devices for diagnostics and radiation therapy

Ultrasonics - ultrasonic diagnostic equipment

Model Catalog: BVI 9600 SYSTEM (Lot serial: B6001000-B6001549); Model Catalog: BVI 9500 SYSTEM (Lot serial: B5001000-B5001393)

BladderScan BVI 9600 with AortaScan Console

Model Catalog: BVI 9600 SYSTEM (Lot serial: all - contact manufacturer); Model Catalog: AMI 9700 SYSTEM (Lot serial: all - contact manufacturer)

Radiology Devices

BladderScan BVI 9600

BladderScan BVI 9600 with AortaScan mode portable ultrasound instrumentPart number: 0270-0452All Serial Numbers are affectedARTG Number: 165358

Radiology Devices

md

md

Model Catalog: (Lot serial: >10 SEE FSN OR CONTACT MFR)

BODY PRO-LOK PLATFORM

MTSBRT002 | see letter

MD: Indexed-immobilization patient positioning system

Model: 41773G, 41774G, 41772G, Affected: 1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301, C110411401

Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)

Codes: M207190, M212200, M141830, M142280, M144220, M149540, M149550, M149560, M149580, M164440, M164470, M177290, M177330, M177340, M198070, M198100, M285840, M133130, M137690, M138630, M138640, M138650, M165550, M165560, M180420, M180430, M180440, M189150, M217660, M217670, M217680, M217710

Radiology Devices

1

No

Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel

CIVCO Arm Support, REF 106015, distributed as: || (a) Rigid Arm Support, Standard, Set Red (PN: 106015) || (b) Rigid Adj. Arm Support, Set (PN: 106020) || (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) || (d) PB2-BLR Posiboard-2 (PN: 109030) || The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..

Codes: M181690, M194500, M203470, M213330, M216050, M142180, M143110, M149600, 0154710, M158550, M165330, M16900, M169330, M142230, M149650, M236810

Radiology Devices

1

No

Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel

CIVCO Arm Support, REF 106047, distributed as: || (a) Rigid Arm Support, Large, Set, Red (PN: 106047) || (b) PB2-BDLRL (PN: 109040) || (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) || (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) || The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

Lot #'s: M441670, M469970, M469980, M469990, M484910, M484920, M516200, M516210, M516220, M533340, M533350, M533360, M533370, M533380, M533970, M533980, M533990, M534000, M544650, M544660, M544670, M550150, M551490, M554940, M554950, M556540, M556550, M559560, M560740, M575850, M578310, M581730, M591090, M591100, M591110, M591120, M591130, and M599570

Radiology Devices

2

No

Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.

Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. || Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

Lot#'s: M551490 and M550150

Radiology Devices

2

No

Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.

Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. || Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

M475840, M475850, M483080, M184760, M201120, M201220, M201230, M229890, M230450, M248410, M265470, M282270, M307490, M322230, M367370, M370090, M381360, M421260, M431550, M452150, M458370, M488300, M514070, M572510, M576810, M606320, M626250, M639290, M642350, M648020, M540640, M543800, M551990, M592190, M604120, M448100, M477600, M477700, M504340, M504350, M507520, M524270, M544100, M569330, M569340, M590710, M600460, M632390, M643140, M604180, M091360, M109060, M122250, M186540, M202260, M253050, M275630, M308820, M335740, M425050, M457560, M483250, M499390, M547370, M559550, M118570, M206960, M425030, M430820, M085360, M089740, M099100, M107610, M118700, M137600, M201810, M220800, M231940, M353380, M358810, M394960, M425020, M430810, M448670, M476410, M488580, M497660, M547740, M598410, M632210, M633570, M085370, M118680, M155510, M173420, M187860, M205340, M353390, M358170, M358580, M358590, M391700, M391710, M395610, M430800, M451470, M616810, M654380, M118610, M451460, M118650, M139440, M141830, M225010, M338400, M435250, M448680, M463740, M499630, M623350, M119380, M206950, M358560, M358570, M381520, M427660, M440600, M526290, M526300, M118660, M141820, M190870, M272570, M435240, M491500, M508640, M622060, M106080, M118600, M124610, M148440, M268900, M283940, M317630, M358610, M381510, M391680, M484430, M484440, M492320, M526260, M526270, M118710, M148450, M490000, M593130, M162020, M205920, M317680, M210700, M262520, M297390, M317690, M334110, M347120, M369110, M373250, M379350, M385180, M390160, M450210, M500620, M539310, M541330, M541830, M448110, M448120, M460670, M472720, M524230, M534750, M536730, M557450, M566960, M593280, M598060, M627710, M552010, M455790, M480870, M510000, M541140, M541810, M576640, M600450, M609740, M610550, M636940, M643130, M650780, M085390, M120660, M177390, M295660, M352830, M355940, M395670, M408960, M430430, M463720, M530670, M568980, M609970, M620480, M663970, M056500, M096880, M112390, M119730, M232970, M251160, M261840, M304420, M374360, M419670, M440460, M475460, M497670, M545750, M603800, M085550, M089260, M093020, M103030, M105150, M183050, M220960, M293580, M293590, M388690, M419650, M560740, M056760, M103040, M124110, M183060, M234590, M312170, M436670, M436680, M444740, M598550, M639430, M093010, M119280, M120400, M120860, M142690, M158480, M220970, M237740, M242000, M261770, M388700, M407620, M419660, M444950, M598860, M328300, M330340, M345110, M349600, M381530, M464980, M547940, M598070, M624410, M117130, M139400, M142090, M164840, M186690, M190180, M193400, M201660, M205110, M232930, M234630, M275650, M297260, M322700, M327850, M335060, M368160, M423720, M430440, M435750, M456910, M475140, M477930, M504290, M528270, M570840, M576930, M639440, M088430, M089650, M091400, M095990, M102210, M116290, M119930, M124320, M133350, M134540, M135520, M139740, M144670, M163200, M163260, M171240, M179410, M187920, M192750, M202990, M213370, M217330, M223270, M229780, M231960, M245390, M253360, M280960, M299320, M346870, M382670, M394080, M394090, M397380, M423700, M437090, M476650, M542430, M544290, M573360, and M618690

Radiology Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

M367350, M370110, M375100, M381740, M406940, M407750, M413300, M413310, M434210, M436400, M445180, M647110, M093610, M113720, M122370, M153900, M206940, M250330, M250340, M258890, M315660, M333490, M340650, M340660, M418340, M421310, M450400, M465510, M473820, M499620, M519670, M519870, M535840, M560410, M569020, M665970, M085160, M096150, M107000, M130450, M155430, M163490, M203230, M215600, M237160, M280540, M295050, M309920, M315640, M335660, M341050, M395150, M426910, M432250, M445050, M447240, M447250, M457880, M463120, M470960, M472370, M491520, M501960, M572330, M610070, M623730, M626290, M648050, M104430, M105580, M109480, M119300, M123880, M181980, M183080, M205350, M208730, M256600, M288450, M395680, M419700, M490030, M511200, M524900, M530460, M636260, M070240, M084610, M087950, M090510, M093250, M096160, M107010, M113740, M122150, M126430, M130960, M142760, M150120, M151000, M161360, M162170, M175800, M176090, M179600, M188560, M197540, M201760, M204920, M206920, M212520, M226140, M226800, M237170, M239790, M242650, M264850, M273010, M277260, M277580, M281220, M282340, M286970, M287050, M288070, M300220, M303390, M304830, M309930, M322420, M330620, M346280, M352800, M360970, M365460, M374640, M377700, M377710, M382140, M384960, M391930, M395520, M408990, M413270, M414570, M415150, M426920, M431600, M431860, M437370, M445090, M446780, M453070, M454110, M457210, M461430, M466270, M471250, M481240, M489250, M492210, M494110, M500070, M516520, M526820, M542120, M548580, M554010, M569710, M573220, M595220, M601030, M602270, M615780, M623480, M629400, M645460, M655810, M543860, M552040, M557840, M567820, M581180, M582540, M584460, M599110, and M609470

Radiology Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Model: 610-1215, 610-1234, 610-1235, 610-1235T and 610-1236, Affected:

M099850, M102860, M109690, M116920, M121840, M145200, M167240, M177420, M183850, M187880, M197330, M198000, M214900, M223090, M243020, M259940, M275080, M299890, M307610, M323480, M324340, M336880, M371260, M388610, M418830, M468260, M505290, M508000, M595790, M610020, M614660, M619370, M328280, M347150, M354390, M359630, M385190, M397110, M402790, M444170, M473920, M477540, M492030, M499400, M507160, M513450, M525040, M541820, M643750, M030030, M086380, M091280, M102870, M111660, M123680, M126080, M137910, M140300, M145210, M157840, M161840, M167250, M171090, M183020, M189070, M196210, M211180, M212890, M223100, M231440, M237620, M248310, M264360, M281640, M299900, M305420, M307400, M317480, M317770, M330280, M349060, M371270, M375160, M382480, M387010, M401610, M409400, M424530, M450070, M458240, M473700, M503560, M505300, M527200, M538410, M577750, M595800, M601380, M610780, M619380, M645840, M328290, M333440, M333900, M351980, M357390, M357430, M363450, M402800, M435210, M440470, M444240, M445560, M455870, M458780, M465230, M488220, M495560, M505790, M507610, M511470, M527370, M530970, M549930, M568660, M598380, M605200, M609520, M610190, M612150, M626760, M113980, M122090, M124190, M153630, M155540, M165430, M168960, M169740, M175890, M186700, M193520, M231410, M239510, M246180, M257780, M266760, M312790, M362170, M395860, M396870, M410330, M452260, M481510, M492020, M494620, M502320, M572970, M593290, M602160, M657490, M660000, M101260, M104980, M133950, M138380, M143100, M169200, M171950, M187800, M197320, M215100, M240270, M272370, M282240, M284870, M297910, M302490, M302680, M315550, M334520, M351870, M382620, M384290, M439310, M440000, M448600, M456880, M491590, M497000, M502440, M623240, M626430, M663670, M998920, M030040, M105680, M113440, M152150, M152940, M169210, M170230, M171840, M272150, M281840, M281950, M300120, M310780, M314090, M327470, M330010, M345300, M374880, M376770, M382630, M384280, M395870, M401010, M404110, M450390, M480400, M481490, M491580, M494340, M502340, M504250, M576110, M594750, M623230, M636250, M643670, M654360, M659160, M481500, M492040, M593520, M424160, and M472500

Radiology Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

M116270, M119900, M121920, M125640, M130290, M170900, M185950, M204790, M211280, M215550, M235410, M240880, M252870, M303130, M320620, M320660, M346050, M368820, M379870, M391260, M395270, M418200, M476020, M497220, M508200, M594740, M598320, and M624430

Radiology Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

M093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M218560, M240080, M250210, M262470, M308100, M328800, M333890, M371670, M384130, M396710, M399210, M399320, M399340, M403640, M412450, M421190, M423310, M424480, M451230, M457640, M461290, M468590, M470900, M473810, M487020, M511040, M545900, M545910, M547320, M560870, M570280, M570290, M585600, M585610, M586670, M594480, M600470, M609760, M611000, M632640, and M643150

Radiology Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Lot numbers: M431760, M431710, M426580, M430200, M423010

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.

CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. || The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.