2024年3月1日，Sleepnet公司开始在全球范围内召回所有带有磁铁的CPAP和BIPAP面罩，因为它们可能干扰某些医疗器械。 当磁铁靠近某些医疗植入物或金属植入物时，可能会干扰植入物的性能或位置，可能导致严重伤害或死亡。
自2006年以来，Sleepnet一直在全球范围内分发带有磁铁的面罩，迄今为止，没有与Sleepnet带有磁铁的口罩相关的医疗器械报告。这是一项基于上市后监测信息的自愿行动。
受影响的面罩包括以下：
Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask.
如果与面罩有密切物理接触的患者或任何人（例如:家庭成员、床伴、护理人员等），其有源医疗植入物或金属植入物会与面罩上的磁铁发生作用，不应使用这些带有磁铁的面罩。
植入物的例子包括但不限于起搏器、植入式心律转复除颤器（ICD）、神经刺激器、动脉瘤夹、金属支架、眼部植入物、胰岛素/输液泵、脑脊液（CSF）分流器、栓塞线圈、金属碎片、植入磁体以恢复听力或平衡的植入物（如耳蜗植入物）、流动中断装置、金属隐形眼镜、牙科植入物、金属颅骨板、螺钉、钻孔盖、骨替代装置、放置在上肢、躯干或更高部位的磁性金属植入物/电极/阀门等。
Sleepnet公司在受影响面罩的使用说明中增加了以下新的禁忌症和更新的警告：
• New Contraindication：
Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs , torso, or higher, etc. If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.
• Updated Warning
Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.
