Reported Dec 12, 2018 · Terminated
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce…
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 6 Slice (Air)
- Model 728256 Product UsageComputed 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
- Lot codes and dates
- System Serial Number_3616 3132.F 3273/8898 334/30006 3432_ 3528_ 3561_ 365/30010 4173-01 4229-03 4256-03 4447-01 447*008-Brilliance 728256_603-1837 728256_803-1616 9799/9790 SN3432
740 of 740 codes
36530013002300330043005300630093014301930213022302430253026302830293030303230333034303530363037303930443045304630483049305130523053305430553056305830603061306230633064306530663067306830693071307330743075307630773078307930803081308330843086
- System Serial Number
- Amount recalled
- 6,343 units in total
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
- Nationwide
Why it was recalled
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
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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