Health product recall

Infinity® Central Station

Last updated

Summary

Product
Infinity® Central Station
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Infinity® Centralstation Wide All lots. MS26800
Infinity® Central Station All lots. MS 18500 MS26800
Infinity® M300+ All lots. MS33648 MS33659 MS33950
Infinity® M300 All lots. MS 25755 MS18501 MS 26076

Issue

During our global market surveillance activities, we have become aware of cases in which the software on the Infinity® Central Station drops peaks on narrow waveforms causing the Infinity® M300 to fail the requirements of the standard IEC 60601-2-27.

Recall start date: March 9, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - General hospital and personal use
Companies

Draeger Medical Systems, Inc.

3135 Quarry Road, Telford, Pennsylvania, United States, 18969

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-73365