Draeger Medical Systems Infinity Acute Care System — Class II medical device recall Z-2734-2017
Terminated recall by Draegar Medical Systems, Inc., reported 2017-07-26, distributed in AZ, NH, SD, TN, TX. Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alar
| Recall number | Z-2734-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draegar Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2017-06-06 |
| Classified | 2017-07-14 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2018-06-19 |
| Distributed | AZ, NH, SD, TN, TX |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CR, DE, ES, FR, GB, HK, IE, IN, IT, JP, KR, MY, NL, PL, PT, SE, TH, TR, ZA |
| Serial numbers | 337018060, 337018078, 343415011, 344034032, 344035021, 344035033, 344035044, 344035053, 344038069, 350597089, 350598048, 350599032, 350602014, 350602037, 350602046, 350602060, 350603012, 350603040, 350603044, 350603047, 350603049, 350603073, 350603074, 352066008, 354214100 and 475 more |
| Model numbers | MK31501/MK31701/MK31722 |
Product
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Reason for recall
Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
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-2734-2017. 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.