Devices

Device Recall GEMINI TF PET/CT Scanners

Model / Serial
The affected Serial Numbers are: Gemini TF 16 Slice: 7005, 7052, 7087, 7112, 7121, 7138, 7115, 7135, 7006, 7008, 7015, 7021, 7020, 7026, 7035, 7039, 7041, 7049, 7053, 7058, 7060, 7069, 7075, 7080, 7083, 7084, 7098, 7117, 7118, 7142; Gemini TF 16 Slice Mobile: 7059, 7104; Gemini TF 64 Slice Mobile: 7092; Gemini TF 64 Slice: 7012, 7013, 7032, 7071, 7082, 7091, 7126, 7132, 7088, 7103, 7136, 7027, 7109, 7105, 7028, 7167, 7078, and 7110.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Puerto Rico, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, and Sweden.
Product Description
Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the following affected CT/PET scanning device systems : GEMINI TF CT/PET Systems 16 Slice, GEMINI TF CT/PET System 16 Slice Mobile; GEMINI TF CT/PET System 64 Slice Mobile; and GEMINI TF CT/PET System 64 Slice. (Model Numbers: 16 slice: 4535 679 83931; 64 slice Mobile: 4535 674 47551; and 64 slice: 4535 679 94741.
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
- Recall of Device Recall GEMINI TF PET/CT Scanners

Manufacturer

Philips Medical Systems (Cleveland) Inc

Manufacturer Address
Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
Source
USFDA

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