Z-1346-2020 Class II Terminated
FDA device recall Z-1346-2020 was initiated by Siemens Medical Solutions USA, Inc on January 16, 2020 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated January 4, 2021). Affected quantity: 64 Worldwide/26 Domestic.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- January 16, 2020
- Termination Date
- January 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 Worldwide/26 Domestic
Product Description
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Reason for Recall
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.
Distribution Pattern
Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.
Code Information
Software versions 2.0.49, 2.0.50, 2.0.51