Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Reported: May 4, 2022 Initiated: March 4, 2022 #Z-1012-2022
Product Description
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Reason for Recall
Software issue resulting in temporary loss of central monitoring functionality.
Details
- Recalling Firm
- Draegar Medical Systems, Inc.
- Units Affected
- 1950 (1574 OUS + 376 US)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.. Recalled by Draegar Medical Systems, Inc.. Units affected: 1950 (1574 OUS + 376 US).
Why was this product recalled? ▼
Software issue resulting in temporary loss of central monitoring functionality.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2022. Severity: Moderate. Recall number: Z-1012-2022.
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