Reported Feb 14, 2024 · Ongoing
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
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 7500Software Version 5.0
- Model 728333 and Spectral CT 7500 China
Software Version 5.0Model 728340
- Lot codes and dates
- UDI-DI
00884838101111Model 728333
- serial numbers
178 of 178 codes
101971018210175101921017910196101801018810190101811018310178101861018510199101841019810193101871018910195101911019410018100231002710062100721007810079100801008410088101011010410112101171011310116100321004910133101401015210153101661017010171101731017210174100161001510017100191002210021100201002510024
- Model728340
- serial numbers
397022397023397020397024397021397025397027397031397026397033397032397030397028397029397015397016397004397007397005397002397006397008397010397003397011397013397009397012397014397017397019397018
- UDI-DI
- Amount recalled
- US: 33, OUS 177
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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