Reported May 8, 2024 · Ongoing
The Oncology Essentials Package of the Spectral CT imaging system.
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- The Oncology Essentials Package of the Spectral CT imaging system.
- Lot codes and dates
- Model No. 728333
- UDI
(01)00884838101111(21)Serial No. 100691008410169101371016310196101811019910210102061020210139
- Amount recalled
- 12 units
Where it was sold
Why it was recalled
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
This product could cause temporary or reversible health problems — stop using it.
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