FDA Device recall Z-1104-2021
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, p…
- FDA Device
- Class II
- ongoing
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, p… by Draegar Medical Systems, citing 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, th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1104-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-23 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Draegar Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Number - MS25510, MS25520, MS26372 Revisions 24 to 29 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1104-2021%22
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