Health product recall

and Infinity M540 IACS Monitoring Solution With C700 and Infinity P2500 (2019-04-22)

Starting date:
April 22, 2019
Posting date:
January 10, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72061

Last updated: 2020-01-10

Affected Products

  1. IACS Monitoring Solution With C700
  2. Infinity P2500
  3. Infinity M540

Reason

Immediately after the infinity M540 patient monitor has been docked to the M500 docking station and a user discharges a patient from the M540 patient monitor, there is a possibility that the communication between the IACS cockpit and the M540 patient monitor is not established. If the communication is not established, the IACS cockpit will not be able to send any commands to the M540 patient monitor with the exception of the "audio pause". Changes made on the IACS cockpit will not be transferred to the M540 patient monitor, though the changes will be reflected on the IACS cockpit.

Affected products

  1. IACS Monitoring Solution With C700

Lot or serial number
  • 5613496066
  • 5613500775
  • 5613501373
  • 5613503175
  • 5613505173
  • 5613505369
  • 5613505966
  • 5613516865
Model or catalog number

MS25510

Companies
Manufacturer
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES

B. Infinity P2500

Lot or serial number

USLM-0689
USLM-0790

Model or catalog number

MS25520
MS22277-XX

Companies
Manufacturer
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES

C. Infinity M540

Lot or serial number

5613503371
5613507866
5613508767
5613513369

Model or catalog number

MS20401
MS26372
 

Companies
Manufacturer
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES

Date modified: