Infinity Acute Care System — Class II medical device recall Z-2189-2024
Ongoing recall by Draeger Medical Systems, Inc., reported 2024-07-03, distributed nationwide. Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefor
| Recall number | Z-2189-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2024-05-13 |
| Classified | 2024-06-25 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CR, CZ, DE, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LT, LV, MA, MT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TW, UA, UY, VN, ZA |
| Quantity | 34,102 units |
| UPC / GTIN / UDI-DI | 04049098054447 |
| Model numbers | MS20407 |
Product
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Reason for recall
Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
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-2189-2024. 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.