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Health product recall

V60 Ventilator, Symbols Only, With Cflex and Avaps Options

Starting date:
April 25, 2017
Posting date:
June 5, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-63464

Reason

Over time, low-frequency vibrations can cause the pins within the female connectors on the internal motor controller to data acquisition board ribbon cable to become partially displaced, which causes momentary high resistance that interferes with data transfer. This may cause the ventilator to fail power on self testing (post) or cause continuous built in test (CBIT) to detect a fault and lead to a ventilator shut down with alarm during use or during intra-hospital transport.

Affected products

V60 Ventilator, Symbols Only, With Cflex and Avaps Options

Lot or serial number

All lots

Model or catalog number

1053614

Companies

Manufacturer
Respironics California, Inc.
2271 Cosmos Court
Carlsbad
92011
California
UNITED STATES