—#50795

Product

Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041955, K042935
Affected lot / code info: Serial #s: 4034-4100, 4102, 4103, 1041

Why it was recalled

A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.

Root cause (FDA determination)

Other

Action the firm took

The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.

Timeline

Recall initiated: 2006-11-06
Posted by FDA: 2007-09-26
Terminated: 2010-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50795. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.