Recall Z-1579-2009 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as an accessory), Catalog #882410, Model Number: 4535 679 71891. CT host. 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation t
| Date | Jul 6, 2009 (initiated Feb 19, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 3 units |
| Distribution | Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051170 | GEMINI GXL Philips Medical Systems (Cleveland), Inc., May 23, 2005 |