Device Recall GEMINI TF PET/CT Scanners

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.

Radiology Devices

2

No

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.

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.