FDA today identified Philips Respironics Trilogy Evo continuous ventilator recall as Class I, over a month after the company initiated the voluntary correction in March.The ventilators affected by the recall — Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal — use a microprocessor-controlled blower to provide pressure support, pressure control, or volume control during breathing support.

在飞利浦呼吸系统三部曲Evo连续呼吸机召回事件发生一个多月后，美国食品和药物管理局（FDA）于3月开始自愿整改，今天将其认定为I级。受召回影响的呼吸机-Trilogy EV300，Trilogy Evo O2和Trilogy Evo Universal-使用微处理器控制的鼓风机在呼吸支持期间提供压力支持，压力控制或音量控制。

The recall of the devices comes as a result of the company’s “post market surveillance activities, and subsequent root cause analysis,” due to Philips “intensified… efforts to strengthen patient safety and quality across the company,” according to a statement from Elco van Groningen, Philips global external relations director, sent to MD+DI when the recall was initiated.

根据飞利浦全球对外关系总监Elco van Groningen在召回开始时发给MD+DI的一份声明，这些设备的召回是公司“上市后监测活动和随后的根本原因分析”的结果，这是由于飞利浦“加强了……加强了公司患者安全和质量的努力”。

The recall is considered a correction, not a product removal.Notifying customers on March 19 through an Urgent Medical Device Correction Notice, Philips urged users to update the ventilators to the latest software version (1.05.06.00) due to a possible power malfunction that can cause the device to issue a “battery depleted” or “loss of power” alarm “while sufficient power is still available, resulting in a sudden loss of ventilation while the device alarms,” according to the FDA filing.

召回被认为是一种纠正，而不是产品删除。3月19日，飞利浦通过紧急医疗器械纠正通知通知客户，敦促用户将呼吸机更新为最新软件版本（1.05.06.00），因为可能存在电源故障，导致设备在仍有足够电源的情况下发出“电池耗尽”或“失电”警报，导致设备警报时突然失去通风”，据FDA备案。

“All Trilogy Evo ventilators… are susceptible to this problem except those ventilators with the software version 1.05.06.00 installed.”The loss of power alarm will stop therapy while operating on battery power alone. A battery depleted alarm, however, will continue therapy if plugged into a permanent power source like AC or DC power.

“除安装了软件版本1.05.06.00的呼吸机外，所有Trilogy Evo呼吸机……都容易出现此问题。”断电警报将在仅使用电池电源的情况下停止治疗。然而，如果插入永久电源（如交流或直流电源），电池耗尽的警报将继续治疗。

The issue has been reported to happen when the ventilators have software other than version 1.05.06.00 installed, are operating in CPAP or PSV mode, and are not able to detect the respiratory effort.

据报道，当呼吸机安装了1.05.06.00版本以外的软件，在CPAP或PSV模式下运行，并且无法检测到呼吸努力时，就会发生此问题。