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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