Company: Draeger Medical Systems, Inc.
Date of Enforcement Report: 4/27/2023
Class II
PRODUCT
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Recall Number:
Z-1471-2023
REASON:
The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual
RECALLING FIRM/MANUFACTURER:
Draeger Medical Systems, Inc
VOLUME OF PRODUCT IN COMMERCE:
6803 systems
DISTRIBUTION:
Worldwide – US Nationwide distribution.
