FDA Device recall Z-2189-2024
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407
- FDA Device
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407 by Draeger Medical Systems, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2189-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-13 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Draeger Medical Systems |
| Distribution | US |
Product
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Reason
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.
Identifiers
| code_info | Model Number: MS20407. UDI-DI: 04049098054447. Rev 20, 21, and 23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2189-2024%22
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