Reported Jun 8, 2016 · Terminated
Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body…
Philips Medical Systems (Cleveland) Inc.
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 (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Ingenuity Core Computed Tomography X-ray Systems
- Product UsageIntended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
- Lot codes and dates
- Model No. 728321
- S/N
300 of 300 codes
310135310257520353330683100133084520005200752008520105201252013520145201552018520195202052021520225202452025520265202752029520305203152032520335203452036520375203852039520405204152042520435204452045520465204752048520505205252053520545205552056520575205852059520615206352064520655206652067520685206952070
- Amount recalled
- 300 Units
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 firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
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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