Infinity® Central Station
Brand(s)
Dernière mise à jour
Summary
Produit
Infinity® Central Station
Problème
Medical devices - Performance issue
Ce qu’il faut faire
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 |
Infinity® M300+ |
All lots. |
MS33648 |
Infinity® M300 |
All lots. |
MS 25755 |
Problème
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: 2023-03-22
Type d’avis ou de rappel
Health product recall
Catégorie
Health product - Medical device - Cardiovascular
Health product - Medical device - General hospital and personal use
Entreprises
Draeger Medical Systems, Inc.
3135 Quarry Road, Telford, Pennsylvania, United States, 18969
Published by
Health Canada
Audience
Healthcare
Classe de rappel
Type I
Identification number
RA-73365