1 — Class II medical device recall Z-0499-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-01-26, distributed nationwide. Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12
| Recall number | Z-0499-2022 |
|---|---|
| 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 | 2021-11-23 |
| Classified | 2022-01-14 |
| Reported by FDA | 2022-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,047 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869010137, 04056869010199, 04056869010205 |
| Serial numbers | 100005, 100006, 100070, 100071, 100074, 100163, 100208, 100209, 100216, 100231, 100263, 100306, 100309, 100345, 100416, 100422, 101083, 101099, 101100, 101101, 102008, 102010, 102138, 102143, 102145 and 157 more |
Product
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.
Reason for recall
Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.
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-0499-2022. 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.