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| Respironics is warning of dangerous software problems with some of its V60 ventilators.--Courtesy of Philips Healthcare |
Respironics, a division of Philips Healthcare ($PHG), has again run into trouble with its ventilators, this time over a software malfunction, and the FDA warns that the problem could lead to patient injury or death.
If a component fails on the V60 ventilator, the device can cut off breathing support with no audible alarm, leaving its pediatric users at risk for serious injury, the FDA said. Philips informed customers of the problem earlier this month, deploying engineers to update the software and get V60s back to normal operation.
The FDA has assigned a Class I label to the recall, a designation it reserves for malfunctions that can lead to death. The agency is asking affected customers and patients to report any adverse events through its online MedWatch system.
The V60 problem is Philips' third ventilator recall in about a year. In September, the FDA slapped the Class I label on a manufacturing issue with the same device, in which some of V60's impellers were improperly attached to the blower motor shaft, possibly coming loose and causing the blower to cease functioning. In August, the agency applied its most serious tag to a recall of Trilogy ventilators, warning that faulty power supply components could lead the devices to shut down without warning.
Philips bought Respironics for $5.2 billion back in 2008. The company produces devices to help patients breathe, sleep and take respiratory therapies.
- read the FDA's note