FDA recall Z-1012-2022

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2022-03-04

Report date

2022-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2022