Class 1 Recall: Respironics California, Inc., V60 Ventilators
Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly...
Tue Jun 04 2013
To find Respironics Material P/N (Philips 12 Digit P/N) and Serial Numbers that are affected by this recall please see: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=118739
The recalled products were manufactured from March, 2009 through April, 2013 and distributed from November 16, 2009 through March 28, 2013.
Use: The Respironics V60 ventilator provides continuous or intermittent breathing support to pediatric patients weighing 44 pounds or greater to adult patients. This ventilator is used in hospitals or other health care facilities under the direction of qualified medical professionals such as physicians, nurses, and respiratory therapists.
Recalling Firm:
Respironics California, Inc.
2271 Cosmos Court
Carlsbad, California 92011-1517
Reason for Recall: Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator. This recalled product may cause serious adverse health consequences, including death.