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840 Ventilator System - Main Unit (2014-06-10)
- Starting date:
- June 10, 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-40399
Recalled Products
840 Ventilator System - Main Unit
Reason
Customer reports have included the GUI display screens (both upper and lower) becoming blank during patient use. This event interferes with the clinician's ability to view and/or change ventilator setting or clinician-set patient alarm parameters. The ventilator continues to provide respiratory support during these events. All ventilator alarms remain active and will activate if alarm limits are exceeded.
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