Recall Z-1346-2020 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
| Date | Jan 16, 2020 |
| Status | Terminated |
| Reason | A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location. |
| Root cause | Software Design Change |
| Action | The firm started notifying customers on January 16, 2020, with letters titled Urgent Medical Device Correction. Customers were advised of the product safety issue. To avoid the possibility of an incorrect alignment of the patient, the user must ensure that filtered images arrive on the COHERENCE Oncologist, or apply any additional filters to the image BEFORE using the "interactive shift" or "landmark registration" tools. The firm will be offering a software solution for the issue free of charge. The firm's letter stated that based on their investigation, customers may continue to use their de |
| Quantity | 64 Worldwide/26 Domestic |
| Distribution | Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060633 | COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 Siemens Medical Solutions USA, Inc., May 1, 2006 |