Tag: Ozone
SoClean issues field correction
November 27, 2023HME News Staff
PETERBOROUGH, N.H. – SoClean on Nov. 16 issued an urgent medical device field correction that provides clarifications to the user manuals for its SoClean2 and SoClean 3 and notifies users of the availability of a hose and mask adapter for the maintenance systems.
SoClean is revising its labeling to incorporate additional warnings and contraindications, as well as proper and consistent device setup instructions, including use of a hose and mask adapter to reduce potential risks associated...
SoClean amends complaint
December 6, 2021HME News Staff
PETERBOROUGH, N.H. – SoClean has filed an amended complaint in its lawsuit against Philips that takes into account a new inspection report from the U.S. Food and Drug Administration.
The company highlighted the following points in the amended complaint:
“Philips has known for years that the company’s products created a serious risk of harm to consumers.”
“The FDA report also confirmed that Philips had been receiving customer complaints...
Philips issues recall
June 14, 2021HME News Staff
AMSTERDAM – Royal Philips has announced, in consultation with regulatory agencies, a voluntary recall notification on certain Bi-Level CPAP, CPAP and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.
The majority of affected devices within the advised five-year service life are in the first-generation DreamStation product family, the company says.
“We...
CPAP manufacturers address certain cleaning devices
March 6, 2020Liz Beaulieu, Editor
YARMOUTH, Maine - Two of the largest manufacturers of CPAP devices say using ozone to clean and sanitize their products may affect warranties.
Philips Respironics
In a letter responding to a customer's request for written guidance, Philips Respironics said using SoClean on its DreamStation will not automatically void the warranty, but the company “reserves the right to void a warranty if it is determined that the use of SoClean caused a defect for which a device otherwise under warranty...
Makers of CPAP cleaning devices respond
March 6, 2020Liz Beaulieu, Editor
YARMOUTH, Maine - SoClean will cover the cost of repairs for three years “in the unlikely event” that ozone from its product damages ResMed's AirSense 10.
SoClean told its partners in a letter that if a patient uses its cleaning device with an AirSense 10 that was purchased on or after Feb. 1, the company will cover the cost to repair the CPAP device during the initial two-year warranty period “in the unlikely event the AirSense 10 shows validated damage consistent with the...