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