Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory
Summary
The FDA issued a Class II for Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse o by Draeger Medical Systems, Inc.. Reason: The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response r.
Details
Source
Device Recall
External ID
Z-1472-2023
Action Date
2023-05-03
Status
Ongoing
Category
device
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,
Lot/Code Info: UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 and lower
Quantity Affected: 19,429 systems
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
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-05
Company
Andover, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Draeger Medical Systems, Inc. has 14 FDA actions in our database, including 6 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Draeger Medical Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Draeger Medical Systems, Inc. have FDA actions?
Draeger Medical Systems, Inc. has 14 FDA actions in our database, including 6 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1472-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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