Recall Z-1687-2017 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California Inc
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. 10
| Date | Feb 1, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Philips sent an Urgent- Medical Device Letter dated February 1, 2017, to all affected customers. It will be sent the week of February 6, 2017, to inform customers that Respironics is voluntarily recalling all Philips V60 Non Invasive Ventilators (NIV) that have Version 2.20 Software installed. Customers are informed that 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. An audib |
| Quantity | 2512 units |
| Distribution | 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, Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS Respironics, Inc., Apr 5, 2011 |