Ingenuity TF PET/CT. Diagnostic imaging system
FDA device recall Z-0897-2013 · posted 2013-02-28 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
- Action taken
- Philips Medical Systems (Cleveland), Inc. sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated January 21, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact your local Philips representative or Philips Healthcare office for further information concerning this issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1 Unit
- Distribution
- Distributed only in Ohio.
- Date initiated
- 2013-01-21
- Date posted
- 2013-02-28
- Date terminated
- 2013-07-19
- 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 |