Reported Dec 12, 2018 · Terminated
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images…
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 64
- Model 728231 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 Number10046_ 10081_ 10182EBW13108 10206_DUMMY 10799_
2,512 of 2,512 codes
33514891897349140014003401640219009902990309033903590379038904090419043904490459047904890519052905490569058905990629064906590669067906890699070907190729073907490759077908090819086908790899092909390969098909991049105910691079108911291179118
1489_ 1OO82 29049-OLD 327*001-BR64 352*001 4101_45(Shiftedf 4272-08 744-1464 7908_02 90094.. 90137_ 90156_DUMMY 9208A 95025* 95040_ 95042A 95048-OLD 95054-OLD 95144* 95157-OLD 95226_DUMMY 95333_ 95424-OLD 95459_ 95517_ 95567_ 95585/11737/80302 95631-OLD 9701_DUMMY 9801A 9851T 9944_ D10156 DUMMY GYULA02 PROJ5041009 S/N95611 SN90137 SN95514 SN95517 SN957261155-161157-091157-101158-051190-021267-031294-011339-091343-021347-041348-011349-011350-02
- 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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