Reported Nov 4, 2015 · Terminated
Ingenuity Flex Computed Tomography X-ray systems. 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 Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
- Lot codes and dates
- Model No. 728317
- S/N
69 of 69 codes
178807260002260003340002340003345001345002345003345004345005345006345007345010345012345013345014345016345017345018345019345021345022345023345024345025345026345027345028345029345031345032345033345034345035345036345037345038345039345040345041345042345043345044345045345046345048345049345051345201345202345203345204345205345206345207345208345209345210345211
- Amount recalled
- 67 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The firm discovered Ring/Dot artifact due to X-ray measurement error.
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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