Reported Jun 8, 2016 · Terminated
Ingenuity Computed Tomography X-ray Systems Product Usage: 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 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. 728326
- S/N
215 of 215 codes
3001423000330005300063000730008300093001030011300123001330014300153001730018300193002030021300223002530026300273002830029300303003130032300333003430035300363003730038300393004030041300423004330044300453004630049320833210752060300003300004300005300010300011300012300013300014300015300016300017300018300019300020300021
- Amount recalled
- 215 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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