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:
- ROM checksum failure issue may cause intermittent reboots;
- IACS Cockpit PDR settings may revert to default settings after normal shutdown;
- 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