Device product
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Z-1346-2020
Product summary
- Event
- Event 84795
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 Worldwide/26 Domestic
- Official record key
device-enforcement:Z-1346-2020
Official wording
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.
Code information: Software versions 2.0.49, 2.0.50, 2.0.51
Distribution pattern: Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.
Derived failure modes
-
Unknown
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.