Philips' Ventilator Woes Continue With Another FDA Class I Recall

Philips' Ventilator Woes Continue With Another FDA Class I Recall
  • Koninklijke Philips NV's PHG Respironics is recalling Certain V60 and V60 Plus ventilators because a subset of these devices had parts put together using an expired adhesive. 
  • The V60 and V60 Plus devices are used in clinical settings to provide mechanical breathing support to patients who can still breathe independently. 
  • They're indicated for patients who have been hospitalized with conditions like respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea, including adults and children.
  • According to the FDA's notice, the recall stems from the use of an expired adhesive. The outdated material may be less effective at holding parts of the device together, potentially causing damage to those parts if they come loose.
  • The notice cites damage to the internal capacitors. If they're damaged, the machine could stop providing ventilation to a patient, with or without sounding an alarm. 
  • There have been no reports of injuries, adverse health consequences, or death associated with these devices.
  • Distributors and buyers are advised to connect each machine to a remote alarm system and set up external oxygen monitoring to catch device failure as quickly as possible and "always have immediate access to an alternative means of ventilation."
  • If failure does occur, healthcare providers should immediately hand over-breathing support to another device and contact their Philips customer service representative to schedule a repair.
  • Price Action: PHG shares are up 1.01% at $31.09 during the market session on the last check Tuesday.

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