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BiPAP A40 Ventilatory Support System (2017-11-03)
- Starting date:
- November 3, 2017
- Posting date:
- November 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, Healthcare Professionals, General Public
- Identification number:
- RA-65270
Affected products
A. BIPAP A40, CANADA
B. BIPAP A40, CANADA, CORE PACKAGE
Reason
Philips Respironics has identified an issue where a non-conforming part (side panel) was utilized on the BiPAP A40 that affects the mechanical connection between the BiPAP A40 and the detachable battery module. The issue results in the inability to connect the BiPAP A40 device to the detachable battery module during setup before putting the ventilator into operation on a user.
Affected products
A. BIPAP A40, CANADA
Lot or serial number
Not Applicable
Model or catalog number
1111173
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
B. BIPAP A40, CANADA, CORE PACKAGE
Lot or serial number
Not Applicable
Model or catalog number
1111174
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES