Device Recall GE

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Radiology Devices

2

No

Worldwide Distribution--USA (nationwide) including the states of: AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OK, OR, PA, SC, TN,TX, and WI, and the countries of UNITED KINGDOM, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, PORTUGAL NORWAY, NEW ZEALAND, LUXEMBOURG, LEBANON, KOREA, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, DENMARK, CANADA, BELGIUM AUSTRIA, AUSTRALIA FINLAND.

GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188 || Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

The recalled system units are identified as follows: Model Number: 882470, and Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174.

Radiology Devices

2

No

Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.

Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. || The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

The recalled system unit is identified as follows: Model Number: 882471 and Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164.

Radiology Devices

2

No

Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.

Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. || The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

The recalled system units are identified as follows: Model Number: 882476, and Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206.

Radiology Devices

2

No

Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.

Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. || The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

06012008-001 12182008-001 12162008-001  03132009-001  03242009-001 05152009-001  07142009-001  08082009-001 09172009-001 12072009-001 10252009-001 01082010-001 012720100-001 03072010-001 03252010-001 04012010-001 05262010-001 06082010-001 06182010-001 09142010-001 11292010-001 10182010-001 12052010-001 08122009-001 09222009-001 02242010-001 10082009-001 02112010-001 10222010-001 08132009-001 12222010-001  06192009-001 10312010-001 10142009-001 09222010-001 10012009-001 06042009-001  06062009-001 09072009-001 01182010-001 03012010-001 07272010-001 09132010-001 10082010-001 11162010-001 12152009-001 12242009-001 12142009-001 04302010-001 04082010-001 05072010-001 08152010-001

Radiology Devices

2

No

Worldwide Distribution -- USA (nationwide) including the states of AL, CA, FL, ID, NY, NH, NJ, NV, OH, PA, TX, VA and WI., and countries of UNITED ARAB EMIRATES, UKRAINE, UNITED KINGDOM, SWITZERLAND

GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. || The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.