FDA Device recall Z-1346-2020
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
- FDA Device
- Class II
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of COHERENCE Oncologist, Model Nos. 07333680 & 07351898 by Siemens Medical Solutions Usa, citing 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 va….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1346-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-16 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV |
Product
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
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.
Identifiers
| code_info | Software versions 2.0.49, 2.0.50, 2.0.51 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1346-2020%22
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