Infinity Acute Care System — Class II medical device recall Z-1104-2021
Ongoing recall by Draegar Medical Systems, Inc., reported 2021-02-17, distributed nationwide. The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the heade
| Recall number | Z-1104-2021 |
|---|---|
| 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 | 2020-12-23 |
| Classified | 2021-02-10 |
| Reported by FDA | 2021-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CR, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, ID, IE, IL, IN, IT, JP, KE, KR, KW, LT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, SA, SE, SG, SI, TH, TR, TW, VN, ZA |
| Model numbers | MS25510, MS25520, MS26372 |
Product
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
Reason for recall
The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.
Machine access
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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.