Recall Z-0176-2010 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California Inc
RESPIRONICS V60 VENTILATOR
| Date | Nov 11, 2009 (initiated Oct 26, 2009) |
| Status | Terminated |
| Reason | The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can result in power loss during ventilation fo |
| Root cause | Device Design |
| Action | The recall notification was initiated October 26, 2009 with the firm mailing a Urgent Medical Device Field Correction letter to the affected customers. The letter informed the customers of the reason for the notice and how Respironics Field Service Technicians were going to correct this issue. The letter also gave the customers instructions to follow pending the completion of the field inspection/replacement. For questions or additional information contact Respironics US Customer Service at 1.800.345.6443, Option #5 then Option #1. |
| Quantity | 524 |
| Distribution | Nationwide and Internationally to : Libya, Hong Kong, France, Italy, India, Spain, United Kingdom, Germany, Netherlands and Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082660 | V60 VENTILATOR, MODEL V8000 Respironics California, Inc., Jan 9, 2009 |