Draegar recalls specific versions of Infinity CentralStation software for patient monitoring with Infinity M300 devices. This software issue may cause temporary loss of central monitoring functionality. Affected units have unique identifiers listed in the recall notice.
Software issue resulting in temporary loss of central monitoring functionality.
Draegar is recalling specific versions of their Infinity CentralStation software (VG2.1.2 and VG2.1.2 SU12) that are used with Infinity M300 wireless telemetry devices. The software issue can cause temporary loss of central monitoring functionality, which may impact patient safety during monitoring. This recall does not involve physical hardware but software updates.
The software issue causes temporary loss of central monitoring functionality for patient monitoring systems. This means that during certain periods, the system might not properly track patient status, potentially leading to missed alerts or delayed responses. However, the issue is temporary and does not cause permanent damage to the system.
Healthcare facilities using Draegar Infinity CentralStation software versions VG2.1.2 and VG2.1.2 SU12 with Infinity M300 wireless telemetry devices are most at risk. The issue affects the software, not the hardware, and is temporary.
Check if your Infinity CentralStation software version is VG2.1.2 or VG2.1.2 SU12. The unique device identifiers (UDIs) listed in the recall notice include specific serial numbers for US distribution. The software is used with Infinity M300 wireless telemetry devices.
Verify your Infinity CentralStation software version is VG2.1.2 or VG2.1.2 SU12 by checking the device settings or documentation.
Install the corrected software version from Draegar's official website to resolve the temporary monitoring issue.
This recall specifically affects the software versions (VG2.1.2 and VG2.1.2 SU12), not the hardware. The Infinity M300 wireless telemetry devices themselves are not affected.
Check your Infinity CentralStation software version. If it is VG2.1.2 or VG2.1.2 SU12, it is affected. The unique device identifiers (UDIs) listed in the recall notice include specific serial numbers for US distribution.
Install the corrected software version from Draegar's official website to resolve the temporary monitoring issue. The recall does not require discarding or replacing the hardware.
We’ve drafted a message you can send Draegar to request your refund or repair — edit it as you like.
Subject: Recall Z-1012-2022 — Draegar Draegar Hello, I own a Draegar that is covered by recall Z-1012-2022 from Draegar. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
