Health product recall

Infinity® Central Station

Last updated

Summary

Product
Infinity® Central Station
Issue
Medical devices - Performance
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

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