The Infinity Acute Care System — Class II medical device recall Z-0258-2020
Ongoing recall by Draegar Medical Systems, Inc., reported 2019-11-06, distributed nationwide. Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication
| Recall number | Z-0258-2020 |
|---|---|
| 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 | 2019-09-13 |
| Classified | 2019-10-31 |
| Reported by FDA | 2019-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 5,634 |
| Reason classes | software |
| Model numbers | MS25510, MS25520, MS26372 |
Product
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Reason for recall
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
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-0258-2020. 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.