TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase
FDA device recall Z-1579-2009 · posted 2009-07-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software defect results in a the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
- Action taken
- An "URGENT - Field Safety Notice" dated February 12, 2009 was sent via FedEx to domestic customers. The notice described the affected products, issue, involved hazard should problem occur and corrective actions for the customer/user. The letter also notified users/customers that a Philips Healthcare Field Service Engineer will contact and visit their site within 6 months to install a TumorLoc upgrade. Notification will also be sent to the international consignees by Philips personnel. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 3 units
- Distribution
- Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia.
- Date initiated
- 2009-02-19
- Date posted
- 2009-07-06
- Date terminated
- 2012-09-21
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI GXL (K051170) | Philips Medical Systems (Cleveland), Inc. | 2005-05-23 |