Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.
FDA device recall Z-0457-2011 · posted 2010-11-24 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MNT
- Quantity affected
- 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, Malay
- Date initiated
- 2010-07-02
- Date posted
- 2010-11-24
- Date terminated
- 2010-12-01
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V60 VENTILATOR, MODEL V8000 (K082660) | Respironics California, Inc. | 2009-01-09 |