Philips/Respironics recently announced a recall on some of their medical devices including CPAP machines. For more information, or to check if your device is affected by this recall, click the link below: https://www.usa.philips.com/healthcare/e/sleep/communications/src-update...
During the initial global recall of 5.5 million products, only 24,400 deivces were subject to recall in Korea. “We expect to recall approximately 24,400 CPAP and BiPAP devices regarding the initial recall,” a company official had said to Korea Biomedical Review.” Philips Respironics has alre...
On 14th June 2021, Philips Respironics issued a medical device recall notification (US only) and field-safety notice (International Markets) for mechanical ventilator devices including continuous positive airway pressure (CPAP), and bilevel positive airway pressure (bilevel PAP). This was in response...
The recall is for some Philips Respironics DreamStation1 (Uno Remediated Devices), according to the FDA, which identified it as a Class I recall, the most serious type. “Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate...
Based on your country selection, your DME/Distributor/Pharmacy/Institution is responsible for managing the recall on your behalf. * In Australia this is an Urgent Product Defect Correction and in New Zealand this is a Recall for Product Correction ...
Re: Phillips / Philips Respironics recent recall notice discussion thread Post by CyndiLooWho » Thu Sep 02, 2021 6:14 pm Just wanted to add that I also received a new DreamStation 2 today as a recall replacement for my 6 month old DreamStation. I was SHOCKED, esp since I saw my ...
In March, the agency sent a letter to Philips Respironics, notifying the company that it has providedinadequate recall notifications for sleep apnea machinessold since 2019, have left many patients and medical equipment suppliers unaware of the recall and the health risks posed by continuing to use...
Richard Callendar has used a Philips Respironics CPAP machine for years after a bilateral lung transplant and a kidney transplant. "It's about time. This has been going on, there's been complaints about the machine as far back as 2010," Callendar said. ...
The FDA designated the recall of Philips Respironics DreamStation devices as class I. The devices are used in both homes and health care settings to help keep breathing at a regular rhythm. The FDA has designated Philips Respironics’ recall of DreamStation devices as a class I recall, the...
People who have bought, leased or rented certain Philips Respironics sleep apnea machines can now file a claim for restitution. The Dutch medical equipment maker recently agreed to pay at least $479 million to compensate users of 20 different breathing devices and ventilators sold in the United ...