Infinity® Central Station
Brand(s)
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
Get notified
Receive notifications for new and updated recalls and alerts by category.