The U.S. Food and Drug Administration has identified Philips’ November 20 recall of its Panorama 1.0T HFO MR (magnetic resonance) system as Class I.

美国食品和药物管理局已确定飞利浦11月20日召回其Panorama 1.0T HFO MR（磁共振）系统为I级。

Philips recalled the MR devices because of an event in which the structural integrity of the MR system components failed, due to unintended excessive pressure buildup of helium gas during a magnet quench.

飞利浦召回MR设备的原因是，在一次事件中，MR系统组件的结构完整性出现了故障，这是由于在磁铁淬火过程中意外产生了过量的氦气压力。

During a quench of the MR magnet (which Philips said isn’t common), a large amount of helium evaporates and vents outside the building through a venting system. The company explained that the venting system’s structural integrity might be compromised if there’s an unknown blockage and pressure rises too high. .

在磁共振磁体淬火期间（飞利浦表示这并不常见），大量氦气蒸发并通过通风系统排出建筑物外。该公司解释说，如果出现未知堵塞和压力升高过高，通风系统的结构完整性可能会受到影响。。。

Philips explained that Panorama’s magnet may experience unintended quench during normal operation or when initiated in an emergency by pressing the emergency stop button. Possible adverse health consequences from an explosion due to unknown vent blockage can include chemical exposure, lack of oxygen, tissue damage, or trauma caused by debris. .

飞利浦解释说，Panorama的磁铁在正常运行期间或在紧急情况下按下紧急停止按钮启动时可能会出现意外淬火。由于未知的通风口堵塞导致的爆炸可能对健康产生不利影响，包括化学物质暴露、缺氧、组织损伤或碎片造成的创伤。。。

Philips said this was the first explosion event in 22 years of use, with no reports of injury or death. 150 devices were recalled in the U.S.

飞利浦表示，这是22年来首次发生爆炸事件，目前尚无伤亡报告。美国召回了150台设备。

The company’s November 17 Urgent Medical Device Correction Notice requested users immediately discontinue use of impacted MR systems, only start a manual quench in emergencies, and place a “do not use” notice on or near the MRI until inspections are made.

该公司11月17日发布的紧急医疗器械纠正通知要求用户立即停止使用受影响的MR系统，仅在紧急情况下开始手动淬火，并在MRI上或附近放置“请勿使用”通知，直到进行检查。

Philips said a field service engineer will be deployed to inspect the Panorama machine and make repairs as needed.

飞利浦表示，将部署一名现场服务工程师检查全景机器，并根据需要进行维修。