Reported Apr 20, 2016 · Terminated
Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer…
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 64Computed 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
- Lot codes and dates
- Model No. 728231
- S/N
284 of 284 codes
12400190569074909991349251951595299538954995549573957496189625963896469653965696599667967096869689969097039738974097559782981198229833983798389859986298989901990999109917992099239927993099339983998999931002110024100421004710050100511007710092
- Amount recalled
- 285 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 was notified of a software error in which the system may not automatically send all image/data series to remote devices.
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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