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Health product recall

IACS Monitoring Solution with C500 and C700 (2017-06-12)

Starting date:
June 12, 2017
Posting date:
July 7, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals
Identification number:
RA-63902

Affected Products

A. IACS Monitoring Solution with C500

B. IACS Monitoring Solution with C700

Reason

The Infinity Acute Care System Monitoring Solution Cockpits (IACS Monitoring Solution with C500 and IACS Monitoring Solution with C700) with Revision Index 6 or higher that contain 4GB RAM modules may induce a failure that can lead to high memory usage thereby delaying touchscreen operations, and may also lead to not annunciating audio or visual alarms on the cockpit and infinity central station. The M540 will still issue visual alarms.

Affected products

A. IACS Monitoring Solution with C500

Lot or serial number

376587013

402073021

402073030

402073067

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

350603074

352066008

354380009

Model or catalog number

MS25520

Companies
Manufacturer

Draeger Medical Systems, Inc.

3135 Quarry Road

Telford

18969

Pennsylvania

UNITED STATES