FDAFDA · Food and drugs·Recall number Z-0897-2013
Ingenuity TF PET/CT. Diagnostic imaging system
Published March 6, 2013 · Recall initiated: January 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Distributed only in Ohio.
- Lot
- Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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