Respironics California Inc recalls Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilato…

Recall date

February 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1687-2017

FDA classification

Class II

Brand / firm

Respironics California Inc

Sold / distributed

Worldwide Distribution - US Distribution and to the countries of : Argentina, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, Norway, Qatar, Saudi Arabia, Spain, Sweden, Switzerland, Turke…

Why it was recalled

The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709