Philips Respironics Recalls Certain CPAP, BiPAP Machines (1)

(Updates with Philips comments from second bullet.)

US FDA says Philips Respironics is recalling certain reworked DreamStation CPAP and BiPAP machines for the risk that they may deliver inaccurate or insufficient therapy.

• FDA has identified the step as a Class I recall, the most serious type of recall, meaning use of the devices may cause serious injuries or death
• In an emailed statement, Philips said it hasn’t received reports of harm to patients
• “Affected devices may continue to be used in accordance with device instructions for use,” it said
• The company is contacting patients to arrange replacement and return of ...