Reported Jul 4, 2018 · Terminated
Ingenuity TF PET/CT 882442
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 TF PET/CT 882442
- Lot codes and dates
- UDI(01)00884838059443(21)2086
- Serial Number2086
- UDI(01)00884838059443(21)2099
- Serial Number2099
- UDI(01)00884838059443(21)2095
- Serial Number2095
- UDI(01)00884838059443(21)2097
- Serial Number2097
- Amount recalled
- 28 total
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
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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