Reported Oct 12, 2016 · Terminated
Brilliance 64 CT Model Number 728231 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?
- Brilliance 64
- CT Model Number 728231 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
199 of 199 codes
400140165169905690719074909991129134925192809367951595299538954195489549955495599561957395749600961496189625963196389640964696539565965996679670967896869688968997039707971197209738974097559763978197829802980598119822983398379838985998599862
- Amount recalled
- 185
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.
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.
Free recall alerts
Get alerted about new infant & baby recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.