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Health product recall

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