FDA Device recall Z-2734-2017
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
- FDA Device
- Class II
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class II recall of Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722 by Draegar Medical Systems, citing cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2734-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-06 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Draegar Medical Systems |
| Distribution | AZ, NH, SD, TN, TX |
Product
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Reason
Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
Identifiers
| code_info | Serial numbers: US: 401089026 401089022 401089020 401089029 401089031 401089033 401089025 401089028 40108900…Serial numbers: US: 401089026 401089022 401089020 401089029 401089031 401089033 401089025 401089028 401089003 401089014 401089023 401089024 401089037 401089042 401089012 401089021 401089034 401091057 401091014 401091042 401091076 401091063 404234070 404234037 404234011 404234022 404234063 404234095 404234088 404234093 404234010 404234097 OUS: 401089048 401089013 401091016 401091078 401091051 401091060 402073009 402073042 402073027 402073062 402073004 404234014 404234039 404234029 404234040 404234069 404234024 404234044 404234032 404234065 404234056 404234048 404234036 404234038 404234025 404234019 404234013 404234015 374271065 379843052 404234018 404234046 401091098 404234066 404234062 404234068 404234071 404234060 404234079 402073021 402073067 402073030 376587013 401089007 401091035 401091085 401091088 402073089 402073063 404234012 401091011 401091048 401091055 401091039 401091047 401091044 4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2734-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.