FDA Identifies ResMed's Recall Of Certain Ventilator Device Masks With Magnets As Most Serious
FDA Identifies ResMed's Recall Of Certain Ventilator Device Masks With Magnets As Most Serious
Thursday, ResMed Ltd (NYSE:RMD) said it is recalling some of its Continuous Positive Airway Pressure (CPAP) masks with magnets due to possible magnetic interference with certain medical devices.
週四，瑞思邁有限公司（紐約證券交易所代碼：RMD）表示，由於某些醫療設備可能受到磁干擾，它正在召回部分帶磁鐵的持續氣道正壓（CPAP）口罩。
Under certain circumstances, when a magnet is nearby (less than 2 inches) to certain medical implants and devices, it might disrupt their function or position, possibly causing serious harm or death.
在某些情況下，當磁體靠近某些醫療植入物和設備時（小於 2 英寸），它可能會干擾它們的功能或位置，可能造成嚴重傷害或死亡。
The FDA has identified this as a Class I recall, the most serious type of recall.
美國食品和藥物管理局已將其確定爲I類召回，是最嚴重的召回類型。
Also Read: How Sleep Device Player ResMed Is Gaining Philips' Market Share In Flow Generator Market – Analysts Weigh In.
另請閱讀： 睡眠設備公司瑞思邁如何獲得飛利浦在流量發生器市場的市場份額——分析師權衡。
While the existing label advises keeping magnets 2 inches away from affected medical devices, it doesn't list all the specific ones that could be affected by the masks' magnets.
儘管現有標籤建議將磁鐵與受影響的醫療器械保持2英寸的距離，但它並未列出所有可能受到口罩磁鐵影響的具體磁鐵。
ResMed is recalling these masks to update the labels and add more warnings and information to guide patients and healthcare professionals on safe usage when using masks with magnets.
瑞思邁正在召回這些口罩，以更新標籤並添加更多警告和信息，以指導患者和醫療保健專業人員在使用帶磁鐵的口罩時如何安全使用。
This recall and label update came after a review of potential risks to medical implants due to magnetic interference.
此次召回和標籤更新是在審查了磁干擾對醫用植入物造成的潛在風險之後進行的。
The use of affected masks may cause serious adverse health consequences and death.
使用受影響的口罩可能會對健康造成嚴重的不良後果和死亡。
There have been six reported injuries. There have been no reports of death.
據報道，有六人受傷。目前還沒有死亡的報道。
The medical device maker started the recall process on November 20, 2023, and has recalled over 20 million devices in the U.S.
這家醫療器械製造商於2023年11月20日啓動了召回程序，並已在美國召回了超過2000萬臺設備。
The AirFit and AirTouch masks are non-continuous ventilatory devices intended to be used by patients weighing more than 66 lbs. who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy.
AirFit 和 AirTouch 口罩是非連續通氣設備，供體重超過 66 磅的患者使用，這些患者已接受非侵入性氣道正壓 (PAP) 治療，例如 CPAP 或雙級療法。
The masks are meant for reuse by one person at home or by multiple people in hospitals.
這些口罩供一個人在家中重複使用，或供醫院中的多人重複使用。
The devices have magnets on the lower headgear straps and frame connections of CPAP masks. These magnets are there to make wearing the mask more comfortable.
這些設備的下部頭帶和CPAP口罩的框架連接處有磁鐵。這些磁鐵可以讓佩戴口罩更加舒適。
ResMed sent an advisory letter stating to keep the magnets at a safe distance of six inches (150 mm) away from implants or medical devices that could be affected by magnetic interference.
瑞思邁發出了一封諮詢信，表示要將磁體與可能受到磁干擾影響的植入物或醫療設備保持六英寸（150 mm）的安全距離。
ResMed started the recall process on November 20, 2023, and has recalled over 20 million devices in the U.S.
瑞思邁於2023年11月20日啓動召回程序，並已在美國召回了超過2000萬臺設備。
ResMed sent an advisory letter stating to keep the magnets at a safe distance of six inches away from implants or medical devices.
瑞思邁發了一封諮詢信，表示要將磁體與植入物或醫療設備保持六英寸的安全距離。
Price Action: RMD shares are down 0.47% at $177.06 on the last check Friday.
價格走勢：在週五的最後一次支票中，RMD股價下跌0.47％，至177.06美元。
譯文內容由第三人軟體翻譯。