Health product recall

IACS MONITORING SOLUTION WITH C500/C700 & INFINITY M540 (2020-10-08)

Starting date:
October 8, 2020
Posting date:
October 20, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74149



Last updated:
2020-10-20

Affected Products

A. IACS MONITORING SOLUTION WITH C500

B. IACS MONITORING SOLUTION WITH C700

C. INFINITY M540

Reason

When the Infinity Acute Care System (IACS) or M540 Patient Monitor with software version VG7.1 Is used:

  1. ROM checksum failure issue may cause intermittent reboots;
  2. IACS Cockpit PDR settings may revert to default settings after normal shutdown;
  3. IACS Cockpit may not send commands to M540.

Affected products

A. IACS MONITORING SOLUTION WITH C500

Lot or serial number

Multiple lots, contact manufacturer.

Model or catalog number

MS25510

Companies
Manufacturer

Draeger Medical Systems, Inc.

3135 Quarry Road

Telford

18969

Pennsylvania

UNITED STATES


B. IACS MONITORING SOLUTION WITH C700

Lot or serial number

Multiple lots, contact manufacturer.

Model or catalog number

MS25520

Companies
Manufacturer

Draeger Medical Systems, Inc.

3135 Quarry Road

Telford

18969

Pennsylvania

UNITED STATES


C. INFINITY M540

Lot or serial number

Multiple lots, contact manufacturer.

Model or catalog number

MS20401

Companies
Manufacturer

Draeger Medical Systems, Inc.

3135 Quarry Road

Telford

18969

Pennsylvania

UNITED STATES