Philips Respironics Recalls Certain Ventilators due to Adhesive Failure
Philips Respironics is recalling more than 1500 ventilators that were distributed in the United States due to the use of an expired adhesive that could ultimately cause the product to fail. The Class I recall involves V60 and V60 Plus Ventilators that were distributed between July 29 and August 11, 2021.
The ventilators are used to support patient breathing.
A “subset” of the products contains parts that were assembled using an expired adhesive, and if this adhesive fails, it could cause the capacitor support bracket to become loose, which could cause the ventilator to stop working. In addition, the failure may or may not trigger an alarm, which could lead to oxygen deprivation, resulting in serious harm and/or death.
Philips Respironics sent an Urgent Medical Device Correction Notice to distributors and customers that include a list of the serial numbers of the recalled products. However, in addition to instructions provided, the company stated, “It is not necessary to remove affected Philips V60/V60 Plus ventilators from service.”
Thus far there have been no reports of injuries, adverse events or patient deaths associated with the use of the recalled devices.
Related Articles
-
The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.
-
Beginning October 1, 2023, the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5).
-
New data presented at the Technology and Heart Failure Therapeutics (THT) Conference showed that hemodynamic monitoring can slow the progression of heart failure in patients with reduced ejection fraction.
-
The acquisition expands Veranex’s footprint for product design engineering services across the U.S., with combined company offices now in the Eastern, Central, and Western regions
