Melissa's Musings(My opinionated view of life)

Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices | FDA : The Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks are worn by a person using bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines to support breathing. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environment. The recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.

Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use | FDA

Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks | FDA

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error | FDA : Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error.

Baxter Issues Urgent Medical Device Correction for All Spectrum IQ Infusion Pumps to Reinforce Important Safety Information Regarding Best Practices for Customer-Initiated IT Network Updates | FDA

Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous — ProPublica : Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts.