RESPIRONICS V60 VENTILATOR
FDA Recall Z-0176-2010 · Posted 2009-11-11
Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeMNT
Date Initiated2009-10-26
Date Terminated2011-10-13
Product Quantity524
Reason for Recall
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
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide and Internationally to : Libya, Hong Kong, France, Italy, India, Spain, United Kingdom, Germany, Netherlands and Saudi Arabia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.