Draeger Infinity M300 and M300+ — Class II medical device recall Z-1472-2023
Ongoing recall by Draeger Medical Systems, Inc., reported 2023-05-03, distributed nationwide. The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail
| Recall number | Z-1472-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2023-04-05 |
| Classified | 2023-04-27 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 19,429 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04049098048989, 04049098095778 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1472-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.