Reported Oct 12, 2016 · Terminated
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product…
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 · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Ingenuity Core 128
- Model Number 728323 Product UsageComputed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
- Lot codes and dates
523 of 523 codes
300163002330024301513200032001320083201032012320133201532016320183202132022320243202632028320323203332034320363203732041320423204332044320463204732048320493205032051320523205332054320553205632057320583205932060320613206232063320643206532066320673206832069320703207132072320733207432075320763207732078
- Amount recalled
- 524
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
This product could cause temporary or reversible health problems — stop using it.
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