RESPIRONICS V60 VENTILATOR
FDA device recall Z-0176-2010 · posted 2009-11-11 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- MNT
- Quantity affected
- 524
- Distribution
- Nationwide and Internationally to : Libya, Hong Kong, France, Italy, India, Spain, United Kingdom, Germany, Netherlands and Saudi Arabia
- Date initiated
- 2009-10-26
- Date posted
- 2009-11-11
- Date terminated
- 2011-10-13
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V60 VENTILATOR, MODEL V8000 (K082660) | Respironics California, Inc. | 2009-01-09 |