Drager Infinity CentralStation Software versions VG2 — Class II medical device recall Z-1012-2022
Ongoing recall by Draegar Medical Systems, Inc., reported 2022-05-04, distributed nationwide. Software issue resulting in temporary loss of central monitoring functionality.
| Recall number | Z-1012-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draegar Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2022-03-04 |
| Classified | 2022-04-27 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04049098001878 |
| Serial numbers | 11097M00313, 11097M00451, 11097M00482, 11097M00661, 11187M00009, 11407M00061, 11407M00119, 11516M00155, 11516M00186, 11516M00314, 11516M00359, 11553M00190, 11553M00212, 11553M00646, 11553M00883, 11731M00230, 11731M00245, 11731M00246, 11802M00360, 12051M00327, 12051M00381, 12051M00412, 12051M00467, 12381M00464, 12381M00473 and 14 more |
Product
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Reason for recall
Software issue resulting in temporary loss of central monitoring functionality.
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-1012-2022. 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.