Sensis/ Sensis Vibe systems with software VD1X as follows: — Class II medical device recall Z-0226-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2021-11-24, distributed nationwide. System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are
| Recall number | Z-0226-2022 |
|---|---|
| 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 | 2021-10-05 |
| Classified | 2021-11-16 |
| Reported by FDA | 2021-11-24 |
| Distributed | Nationwide (US) |
| Quantity | 403 units |
| Serial numbers | 100005, 100006, 100064, 100070, 100071, 100074, 100095, 100097, 100103, 100115, 100116, 100117, 100120, 100121, 100154, 100156, 100157, 100163, 100165, 100175, 100176, 100184, 100208, 100209, 100216 and 381 more |
| Model numbers | 10764561, 11007641, 11007642 |
Product
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
Reason for recall
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
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-0226-2022. 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.