FDA Device recall Z-1012-2022
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12
- FDA Device
- Class II
- ongoing
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 by Draegar Medical Systems, citing software issue resulting in temporary loss of central monitoring functionality.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1012-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-04 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Draegar Medical Systems |
| Distribution | US |
Product
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Reason
Software issue resulting in temporary loss of central monitoring functionality.
Identifiers
| code_info | Unique Device Identifier (UDI) for US distribution: (01)04049098001878(11)200626(21)1OQ84F-01013(93)MS26800-40, (01)04…Unique Device Identifier (UDI) for US distribution: (01)04049098001878(11)200626(21)1OQ84F-01013(93)MS26800-40, (01)04049098001878(11)190516(21)1OQ80D-00211(93)MS26800-36, (01)04049098001878(11)191218(21)1OQ84F-00362(93)MS26800-37, (01)04049098001878(11)200323(21)1OQ84F-00617(93)MS26800-38, (01)04049098001878(11)190903(21)1OQ84F-00103(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00105(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00104(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00099(93)MS26800-37, (01)04049098001878(11)190807(21)1OQ84F-00065(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00081(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00120(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00080(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00070(93)MS26800-36, (01)04049098001878(11)200630(21)1OQ84F-01005(93)MS26800-40, (01)04049098001878(11)190730(21)1OQ80D-00059(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ84F-00043(93 |
|---|
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-1012-2022%22
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