Philips Recalls OmniLab Advanced+ Ventilators Due to Alarm Failure
Philips Respironics has issued a recall for its OmniLab Advanced+ ventilators due to an alarm failure that can lead to therapy interruption or loss of ventilation.
Philips Respironics has issued a recall for its OmniLab Advanced+ ventilators due to an alarm failure that can lead to therapy interruption or loss of ventilation.
Philips Respironics will end the sale of "hospital ventilation products, certain home ventilation products, portable and stationary oxygen concentrators and sleep diagnostic products," according to a company announcement.
The FDA has requested Philips conduct additional testing on its recalled CPAP, BiPAP, and ventilator devices, calling testing to date inadequate to fully evaluate the risks posed to users.
The FDA reports that Philips Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues that may affect performance and safety.
Read MorePhilips Respironics has recalled certain CPAP and BiPAP masks containing magnets that may cause potential injuries or death when the magnets interfere with certain implanted metallic medical devices and metallic objects in the body, according to an FDA alert.
Read MoreCertain Philips BiPAP devices are being recalled due to the potential to release volatile organic compounds (VOCs), according to the FDA.
Read MorePhilips, a producer of respiratory medical devices, announced that the company’s CEO is set to step away from his role.
Read MorePhilips Respironics is recalling all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms, according to an FDA recall alert.
Read MorePhilips Respironics: Submission of a medical device report itself is not evidence that the device caused or contributed to the adverse outcome or event.
Read MorePhilips responds to reports of an increase in medical device reports related to the company’s respiratory device recall.
Read MoreThe FDA is proposing that an order should be issued to require Philips Respironics to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015.Â
Read MorePhilips Respironics issued a recall for its V60 ventilators due to an electrical error that may cause the devices to cease to operate, potentially without setting off an audible/visual alarm.
Read Morecustomers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm.
Read MorePhilips Respironics is recalling certain V60 and V60 Plus ventilators due to an expired adhesive in what the FDA has labeled a Class I recall.
Read MorePhilips Respironics provided an update on the remediation status of certain respiratory care products that were subject to a recall.
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