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Puritan Bennett Ventilator 840 (2013-12-06)
- Starting date:
- December 6, 2013
- Posting date:
- January 13, 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-37467
Recalled products
- Puritan Bennett Ventilator 840
Reason
Covidien is taking voluntary corrective action in the field involving the Puritan Bennett 840 systems equipped with certain software revisions in response to reports by clients of diagnostic code XB0069, which results in an interruption in mechanical ventilation, owing to a software error. The frequency of occurrence of this code is extremely low.
Affected products
A. Puritan Bennett Ventilator 840
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