California-based Respironics, a subsidiary of technology giant Philips (NYSE:PHG), announced today that the FDA slapped its highest-risk label on a recall that affects more than 19,000 units of Respironics’ V60 ventilators.
The V60 devices are assist ventilators used to augment breathing in the hospital or at home for patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea. The federal watchdog agency gave the recall Class I status, defined as a "situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Respironics recalled its V60 ventilators after discovering an issue with the their power management software. The devices may shut down suddenly and cease the flow of ventilator support to a patient, possibly without sounding an alarm.
Respironics initiated the recall on June 4 and was notified of the FDA’s Class I status on June 17, according to a company statement. The device maker said it has already developed a fix and has issued a warning to all distributors, providers, sales personnel and customers that may need the updated software.
This is the 2nd recall affecting the V60 devices. Respironics late last year recalled 116 ventilators after receiving reports of 2 motor failures in the V60 line. Respironics said at the time that the recall was prompted by an issue in the ventilators’ blower assembly.
The FDA’s decision also marks the company’s 2nd Class I recall in as many years, following January 2012’s recall of the Trilogy 100 ventilators for manufacturing issues that the FDA said could result in patient injury or death.