Reported Apr 20, 2016 · Terminated
Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by…
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 Core 128 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
- Lot codes and dates
- Model No. 728323
- S/N
171 of 171 codes
30016300233015130153320003200132008320123204232044320573206132065320673206832069320763210032106321383213932140321413214232143321443214532146321473214832149321503215132152321533215432155321563215732158321593216032161321623216332164321653216632167520235202852049320001320003320006320008320010320024320026320029
- Amount recalled
- 174 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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