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Health product recall

840 Ventilator System - Main Unit (2014-06-12)

Starting date:
June 12, 2014
Posting date:
July 10, 2014
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-40425

Recalled Products

840 Ventilator System - Main Unit 

Reason

This voluntary FSCA is in response to customer reports of the loss of GUI display information due to a power supply unit failure while the ventilator continues to provide breath support.

Affected products

840 Ventilator System - Main Unit 

Lot or serial number

Not applicable

Model or catalog number

4-840120DICU-EN
4-840120DICU-FR

Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES