Philips Medical Systems (Cleveland) Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Serial #s: 4034-4100, 4102, 4103, 1041
Products Sold
Serial #s: 4034-4100, 4102, 4103, 1041
Philips Medical Systems (Cleveland) Inc is recalling Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, due to A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026