Reported Mar 6, 2013 · Terminated
Ingenuity TF PET/CT. Diagnostic imaging system
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. Diagnostic imaging system
- Lot codes and dates
- Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.
- Amount recalled
- 1 Unit
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
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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