Sensis — Class II medical device recall Z-1243-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-06-15, distributed nationwide. Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems.
| Recall number | Z-1243-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-04-13 |
| Classified | 2022-06-06 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 443 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869010137 |
| Serial numbers | 10140973, 10661, 10666, 10700, 10704, 10723, 10764561, 10765502, 10883, 10886, 10887, 10910620, 11053, 11251, 11657, 11661, 11855, 11856, 11882, 13212, 13215, 13218, 13240, 13243, 13272 and 428 more |
| Model numbers | 10140973, 10764561, 10765502, 10910620, 6623974, 6634633, 6634658, 6648153, 6648161 |
Product
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1243-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.