—#74802

Product

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033357, K052640
Affected lot / code info: 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.

Why it was recalled

A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.

Root cause (FDA determination)

Process design

Action the firm took

Philips Medical Systems Nuclear Medicine division initiated this recall by sending a 'Customer Advisory Notification to their customer accounts on 11/24/2008. This notification informs the customer of the potential for the device equipped with the Pulmonary Gating Option to develop an air leak which could result in the device being unable to produce the desired respiratory correlated images. The notification provides field test instructions and recommends that the customer test the bellows on each day of use in order to assess that the unit is functioning properly. If the bellows device fails the test the recalling firm recommends that the unit not be used and that the recalling firm be contacted via telephone or E-mail. The firm intends to conduct a field correction of the affected units in which their Field Service Engineers will install upgrade kits on the affected devices tentatively scheduled to begin in September, 2009.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-11-24
Posted by FDA: 2009-11-17
Terminated: 2010-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74802. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.