Reported Jun 8, 2016 · Terminated
Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the…
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 Product UsageIntended 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
424 of 424 codes
32012332024030016300233015132000320013200832010320123201332015320163201832021320243202632028320323203332034320363203732041320423204332044320463204732048320493205032051320523205332054320553205632057320583205932060320613206232063320643206532067320683206932070320713207232073320743207532076320773207832079
- Amount recalled
- 424 Units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
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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