Philips Diagnostic Imaging Systems Recalled for Database Lockup
Philips Medical Systems is recalling 386 diagnostic imaging systems because the PET Reconstruction Server database may randomly lock up, preventing PET acquisitions and resulting in incomplete studies.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software malfunction causing incomplete diagnostic studies, which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk operational issues.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 386 diagnostic imaging systems, including the GEMINI LXL, TruFlight Select, and various GEMINI TF PET/CT models. The recall involves specific serial numbers for models #882412, #882438, #882470, #882471, #882473, and #882476.
The recall is due to a defect where the PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete. This lockup prevents the PET acquisition from beginning, resulting in an unexpected incomplete study. The source text does not report any injuries, illnesses, or deaths associated with this defect.
The affected products were shipped to numerous states in the United States and to many countries internationally. The source text does not provide specific instructions for consumers or healthcare facilities on how to resolve the issue, nor does it list specific dates for the recall.
The recalled product
- Product
- Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 386
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model #882412
- Serial #'s:14701
- 14702
- 14704
- 14705
- 14706
- 14707
- 14708
- 14709
- 14710 & 14711. Model #882438
- Serial #'s:17002
- 17003
- 17004
- 17005
- 17006
- 17007
- 17008
- 17009
- 17010
- 17011
Distribution
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