Reported Feb 5, 2014 · Terminated
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance…
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?
- Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
- Lot codes and dates
- Brilliance iCT
728306Serial #'s: 100018100040100411100503100506
- Brilliance iCT SP
728311Serial #'s: 200047200121
- Brilliance iCT
- Amount recalled
- 7 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Patient images exhibited ring artifacts.
This product could cause temporary or reversible health problems — stop using it.
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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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