|Philips Healthcare's Respironics is recalling some of its V60 ventilators over a motor malfunction--courtesy of Philips Healthcare|
Philips Healthcare's ($PHG) Respironics is conducting its second ventilator recall in as many months, this time calling back some of its V60 ventilators over possible motor failure.
Respironics says the issue effects 116 of its devices, and the company notified customers on July 31 and has already updated 33 of the units.
The issue: During manufacturing, some devices' impellers were improperly attached to the blower motor shaft, possibly coming loose and causing the blower to cease functioning, Respironics said. If that happens, the unit will shut down, putting patients at risk.
The FDA is aware of the recall but has yet to assign it a classification. In the meantime, the agency is asking physicians and patients to report related adverse events through its online MedWatch system.
Last month, Respironics got a Class I label--the FDA's most serious designation--for its April recall of Trilogy ventilators. Those devices were plagued by faulty power supplies that could cause them to shut off without warning, also disabling their built-in alarms. The malfunction put patients at risk for injury or death, the FDA said, and Respironics says it reclaimed all of the recalled devices.
Philips bought Respironics for $5.2 billion back in 2008. The company produces devices to help patients breathe, sleep and take respiratory therapies.
- read Respironics' release
- see the list of affected serial numbers (PDF)
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