Ingenuity TF PET/CT. Diagnostic imaging system recall
Ingenuity TF PET/CT. Diagnostic imaging system
Why was Ingenuity TF PET/CT. Diagnostic imaging system recalled?
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.
- Product
- Ingenuity TF PET/CT. Diagnostic imaging system
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 1 Unit
- Distribution
- Distributed only in Ohio.
- Recall date
- March 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)