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From the category archives:
Respironics has issued a voluntary recall on two models of its SmartMonitor 2 Infant Apnea monitor after being notified by the U.S. Food and Drug Administration of potential problems.
The company issued a voluntary Class 1 recall, which are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
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ResMed, one of the leading manufacturers of equipment used to treat sleep apnea, has issued a worldwide recall for more than one-quarter of a million CPAP machines due to a potential risk with the power supply connector that may end up costing the company an estimated $210 million to correct.
In a press release, the company indicated that specific S8 devices manufactured between July 2004 and May 15, 2006, risk a potential short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator.
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