Recall Z-0457-2011 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California Inc
Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.
| Date | Nov 24, 2010 (initiated Jul 2, 2010) |
| Status | Terminated |
| Reason | Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage. |
| Root cause | Device Design |
| Action | Phililps Healthcare issued an Urgent Medical Device Field Correction letter dated July 2, 2010 concerning the RespironicsV60 Ventilator issue. Customers will be contacted by US Field Service Technicians and international distributors to schedule and perform inspections and replacement of the affected component. The unit may continue to be used pending completion of the field inspection. Customers may contact Respironics US Customer Service about this action at 1 800 345 6443, option #5, then option #1. |
| Quantity | 504 |
| Distribution | Worldwide Distribution: Throughout the US and Puerto Rico,, and to the countries of: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, India, Italy, Kenya, Kuwait, Libya, Malaysia, Oman, Netherlands, Norway, the United Kingdom, Saudi Arabia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082660 | V60 VENTILATOR, MODEL V8000 Respironics California, Inc., Jan 9, 2009 |