Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.

FDA Recall Z-0457-2011 · Posted 2010-11-24

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeMNT
Date Initiated2010-07-02
Date Terminated2010-12-01
Product Quantity504

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082660V60 VENTILATOR, MODEL V8000Respironics California, Inc. · 2009-01-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑