Health product recall

V60 Ventilator, Symbols Only, with CFLEX and AVAPS Options (2019-09-18)

Starting date:
September 18, 2019
Posting date:
October 3, 2019
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-71145

Last updated: 2019-10-03

Affected Products

V60 Ventilator, Symbols Only, with CFLEX and AVAPS Options

Reason

The touchscreen must be used to change certain therapy settings. The touchscreens in affected units may become frozen and fail to respond to touch commands. Consequently, if a patient requires a change in a ventilator therapy setting, e.g., FIO2, the change could not be made. Although it would be immediately apparent to the user that the changes cannot be made, there is no advance warning of touchscreen failure.
 

Affected products

V60 Ventilator, Symbols Only, with CFLEX and AVAPS Options

Lot or serial number

Not applicable.

Model or catalog number

1053614

Companies
Manufacturer
Respironics California LLC
2271 Cosmos court
Carlsbad
92011
California
UNITED STATES