Reported Oct 12, 2016 · Terminated
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional…
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 Model Number 728321 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
358 of 358 codes
300413100133084520005200452007520085201052012520135201452015520185201952020520215202252024520255202652027520295203052031520325203352034520355203652037520385203952040520415204252043520445204552046520475204852050250525205352054520555205652057520585205952061520635206452065520675206852069520705207152072
- Amount recalled
- 358
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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