Z-1472-2023 Class II Ongoing
FDA device recall Z-1472-2023 was initiated by Draeger Medical Systems, Inc. on April 5, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 19,429 systems.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- April 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,429 systems
Product Description
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 and lower