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The FDA has provided an update on Philips Respironics’ recall of almost 18.7 million masks for use with bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines, deeming the recall Class 1 because of the risk of serious injury or death. Read More
Insulet has sent letters to users of its Omnipod DASH insulin management system with a warning about defective batteries in the personal diabetes manager (PDM) controller device. Read More
The FDA said the benefits of using Coloplast’s Restorelle mesh device for transvaginal repair of pelvic organ prolapse do not outweigh the risks, based on findings from a postmarket surveillance study. Read More
Prostate cancer patients treated with Accuray’s CyberKnife robotic radiotherapy needed fewer sessions compared to patients treated with conventional radiotherapy, researchers reported in the journal The Lancet Oncology. Read More
If exploited, an attacker could access patient information and obtain additional access to various services associated with Vitrea View, said Trustwave Spiderlabs. Read More
The recall is not associated with a June 2021 recall of the company’s BiPAP machines because of an issue with a foam material, the agency noted. Read More
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