Respironics California, Inc. - Class 1 Recall: V60 Ventilators - Issue with software

[Posted 06/20/2013]

AUDIENCE: Risk Manager, Anesthesiologist, Surgeon

ISSUE: 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.

The recalled products were distributed from November 16, 2009 through March 28, 2013.

BACKGROUND: On June 3, 2013, Philips Healthcare sent a "MEDICAL DEVICE CORRECTION" letter to all customers who received the V60 Ventilators. The letter described the product, the problem, and the actions to be taken.

RECOMMENDATION: Customers were informed that the V60 ventilator may continue to be used according to its directions for use, pending the completion of the software update. In addition, customers were instructed to refer to their manual for additional information on warnings.

A Philips Field Service Engineer, Approved Service Provider, or Distributor will be contacting customers to schedule a no-cost update and replacement of the Power Management Board Assembly Software on all V60 ventilators shipped from the manufacturer prior to April 1, 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=118739¹

Customers were instructed to contact their local Philips Respironics representative at 1-800-722-9377 for any further information or support concerning this issue.

[6/20/2013 - Recall Notice - FDA]