Philips Medical Systems (Cleveland) Inc Gemini PET/CT sytem, Dual Configuration Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gemini PET/CT sytem, Dual Configuration
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
All codes.
Products Sold
All codes.
Philips Medical Systems (Cleveland) Inc is recalling Gemini PET/CT sytem, Dual Configuration due to When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
Recommended Action
Per FDA guidance
The firm sent recall/field correction letters dated 3/11/05.
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 noticePage updated: Jan 10, 2026