Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomog
FDA device recall Z-1029-2013 · posted 2013-04-01 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- 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.
- Action taken
- Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated December 19, 2012 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. A Philips Service Engineer will contact the customer for implementation of the software update on the affected system.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1
- Distribution
- Distributed to one customer in Ohio.
- Date initiated
- 2012-12-20
- Date posted
- 2013-04-01
- Date terminated
- 2013-06-18
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI RAPTOR (K052640) | Philips Medical Systems (Cleveland), Inc. | 2005-10-07 |