Ventilator systems used at the hospital level have been recalled due to a software defect that could cause severe adverse health consequences and even death.
A Respironics V60 ventilator recall was announced by the FDA on June 4, after the manufacturer learned that the power management board assembly in the V60 ventilator has the capability to fail and cause ventilator support to be lost without the alarm signaling a malfunction.
The V60 ventilators are used to provide continuous and intermittent breathing support to patients weighing from 44 pounds to adults and are used in hospitals or other health care facilities by trained and qualified medical professionals.
The recall affects the V60 Ventilators made by Respironics California Inc. that were manufactured from March 2009 through April 2013, and distributed from November 16, 2009 through March 28, 2013.
On June 3, 2013, Philips Healthcare sent a Medical Device Correction letter to all customers who have received the affected V60 ventilators detailing the products problem and instructions on how to upgrade the software in the power management board assembly. Customers were informed in the letter that they may continue using the ventilators pending the completion of the software upgrade.
The letter sstated that all V60 ventilators manufactured before April 1, 2013 will receive the software upgrade free of charge upon scheduling the appointment for maintenance.
Class I recalls are the most dangerous and serious type of recall because there is reasonable probability that the use of this product will cause severe adverse health consequences and even death.
Consumers should contact their local Philips Respironics representative at 1-800-722-9377 to schedule the upgrade and for any further questions regarding the product.