Ingenuity TF PET/CT. Diagnostic imaging system that recall: Software Issue
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Why was Ingenuity TF PET/CT. Diagnostic imaging system that recalled?
Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.
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
- Product
- Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 1
- Distribution
- Distributed to one customer in Ohio.
- Recall date
- April 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)