Reported Feb 14, 2024 · Ongoing
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Philips Medical Systems
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 MEDICAL SYSTEMS · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Spectral CT on Rails
Software Version 5.1.0.Xmodel 728334
- Lot codes and dates
- UDI-DI00884838103627
- serial number1005
- Amount recalled
- US: 1
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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