FDA Device recall Z-1243-2022
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620 by Siemens Medical Solutions Usa, citing siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cann….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1243-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-13 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Reason
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Identifiers
| code_info | UDI-DI: 04056869010137 Material Serial 6623974 40108 6623974 41202 6623974 41017 6623974 42308 6623974 6101 6623974 41…UDI-DI: 04056869010137 Material Serial 6623974 40108 6623974 41202 6623974 41017 6623974 42308 6623974 6101 6623974 41021 6623974 6110 6623974 6622 6623974 6727 6634633 3021 6634633 2272 6634633 2563 6634633 2589 6634633 20380 6634633 3112 6634633 2291 6634633 3405 6634633 3406 6634633 3440 6634633 3407 6634633 3408 6634633 3437 6634633 22267 6634633 21334 6634633 3417 6634633 3564 6634633 2060 6634633 2154 6634633 2155 6634633 2201 6634633 3037 6634633 3038 6634633 3041 6634633 3166 6634633 3224 6634633 3226 6634633 3352 6634633 3534 6634633 3536 6634633 20102 6634633 20134 6634633 20137 6634633 20149 6634633 20314 6634633 22688 6634633 2520 6634633 2521 6634633 2506 6634633 2709 6634633 2739 6634633 3072 6634633 21212 6634633 2552 6634633 2744 6634633 3060 6634633 20062 6634633 20574 6634633 2442 6634633 2444 6634633 2500 6634633 2501 6634633 2025 6634633 2276 6634633 2408 6634633 3622 6634633 3650 6634633 3653 6634633 3670 6634633 3671 6634633 3676 6634633 2578 6634633 22427 663463 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1243-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.