Public recall detail

Infinity® Central Station

2023-03-22

medium
Recall Safety notice
Quick summary

Quick summary: Infinity® Central Station. Date: 2023-03-22.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Infinity® Central Station. Date: 2023-03-22.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandDraeger Medical Systems, Inc.
ProductInfinity® Central Station
IssueMedical devices - Performance
Recall classType I
IdentificationRA-73365

Affected products

ProductInfinity® Centralstation Wide
LotAll lots.
ModelMS26800
Serial numberAll lots.
DescriptionInfinity® Centralstation Wide
ProductInfinity® Central Station
LotAll lots.
ModelMS 18500 MS26800
Serial numberAll lots.
DescriptionInfinity® Central Station
ProductInfinity® M300+
LotAll lots.
ModelMS33648 MS33659 MS33950
Serial numberAll lots.
DescriptionInfinity® M300+
ProductInfinity® M300
LotAll lots.
ModelMS 25755 MS18501 MS 26076
Serial numberAll lots.
DescriptionInfinity® M300

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular Health products - Medical devices - General hospital and personal use
CompaniesDraeger Medical Systems, Inc. 3135 Quarry Road, Telford, Pennsylvania, United States, 18969
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-73365
Background{}
CompaniesDraeger Medical Systems, Inc. 3135 Quarry Road, Telford, Pennsylvania, United States, 18969
AudiencesHealthcare
Source updated2023-03-22

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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