飞利浦关于X射线计算机体层摄影设备主动召回的公告（C&R#2022-PD-CTAMI-110/FCO72800782)

飞利浦作为一家领先的健康科技公司，长期致力于生产和研发能满足客户需求的产品及其创新解决方案。确保患者的生命安全是飞利浦产品质量所追求的最重要的最基础的标准。

飞利浦发现Incisive CT 系统随附的PIM（患者监护仪）电缆存在问题，即如果用户在日常操作中频繁插拔PIM电缆接头，接头和电缆可能会从焊接点处断开进而导致ECG（心电图）信号间歇性丢失影响采集图像的质量。

飞利浦已经向受影响客户发送客户告知信，主动告知有可能发生的问题和如何识别并采取的措施，并安排飞利浦服务工程师到客户现场为客户更新硬件以解决该问题(参见FCO72800782)，这也是飞利浦主动承担责任和义务的体现。

根据中国医疗器械召回法规的相关规定，截止至目前，飞利浦正在为受影响客户发送紧急现场安全通知。此主动召回在中国的召回级别为三级召回。按《医疗器械召回管理办法》第六条内容要求：“医疗器械经营企业、使用单位应当积极协助医疗器械生产企业对缺陷产品进行调查、评估，主动配合生产企业履行召回义务，按照召回计划及时传达、反馈医疗器械召回信息，控制和收回缺陷产品。”

如您在使用受此次主动召回影响的产品，若有任何疑问，请您致电800-810-0038/400-810-0038免费服务热线（7*24小时），或者直接联系您所在区域的经销商或飞利浦销售代表。

受影响设备序列号为：

Incisive CT:

530002, 530003, 530004, 530005, 530006, 530007, 530008, 530009, 530010, 530011, 530012, 530013, 530014, 530015, 530016, 530017, 530018, 530019, 530020, 530021, 530022, 530023, 530024, 530025, 530026, 530027, 530028, 530029, 530030, 530031, 530032, 530033, 530034, 530036, 530037, 530038, 530040, 530041, 530042, 530043, 530044, 530045, 530046, 530047, 530048, 530049, 530050, 530051, 530052, 530053, 530054, 530055, 530056, 530057, 530058, 530059, 530060, 530061, 530062, 530063, 530064, 530065, 530067, 530069, 530070, 530071, 530072, 530074, 530075, 530076, 530079, 530080, 530081, 530082, 530083, 530084, 530085, 530086, 530087, 530089, 530090, 530091, 530092, 530093, 530094, 530095, 530096, 530097, 530098, 530099, 530100, 530101, 530102, 530103, 530104, 530105, 530106, 530107, 530108, 530109, 530110, 530111, 530113, 530114, 530115, 530117, 530118, 530119, 530120, 530121, 530122, 530124, 530125, 530126, 530127, 530128, 530129, 530132, 530133, 530134, 530135, 530136, 530137, 530138, 530139, 530140, 530141, 530142, 530143, 530144, 530145, 530146, 530147, 530148, 530151, 530152, 530153, 530154, 530155, 530156, 530157, 530160, 530161, 530162, 530165, 530166, 530167, 530168, 530169, 530170, 530171, 530172, 530173, 530174, 530175, 530176, 530178, 530179, 530180, 530181, 530182, 530183, 530184, 530187, 530188, 530189, 530191, 530193, 530195, 530196, 530197, 530198, 530200, 530201, 530202, 530203, 530204, 530205, 530206, 530207, 530208, 530211, 530212, 530214, 530215, 530216, 530217, 530218, 530219, 530220, 530221, 530222, 530223, 530224, 530226, 530227, 530228, 530229, 530230, 530231, 530232, 530233, 530234, 530235, 530237, 530239, 530240, 530241, 530242, 530243, 530244, 530245, 530246, 530247, 530248, 530249, 530252, 530253, 530254, 530255, 530257, 530258, 530259, 530260, 530262, 530263, 530264, 530265, 530266, 530267, 530268, 530269, 530270, 530271, 530272, 530273, 530274, 530275, 530276, 530277, 530278, 530279, 530280, 530281, 530282, 530283, 530284, 530285, 530286, 530287, 530288, 530289, 530290, 530291, 530292, 530293, 530295, 530296, 530297, 530298, 530299, 530300, 530302, 530303, 530304, 530305, 530306, 530308, 530309, 530310, 530311, 530312, 530313, 530314, 530315, 530316, 530317, 530319, 530321, 530322, 530323, 530324, 530325, 530326, 530327, 530328, 530330, 530331, 530334, 530336, 530337, 530339, 530343, 530344, 530351, 530352, 530353, 530355, 530356, 530361, 530365, 530366, 530367, 530375, 530376, 530377, 530379, 530380, 530381, 530382, 530383, 530385, 530386, 530387, 530390, 530392, 530394, 530396, 530397, 530398, 530399, 530400, 530401, 530402, 530403, 530405, 530407, 530411, 530413, 530414, 530415, 530416, 530417, 530418, 530422, 530423, 530424, 530425, 530426, 530427, 530428, 530433, 530434, 530439, 530440, 530441, 530442, 530443, 530445, 530446, 530447, 530448, 530450, 530453, 530454, 530455, 530457, 530459, 530463, 530465, 530467, 530468, 530469, 530471, 530472, 530473, 530477, 530479, 530484, 530485, 530487, 530488, 530490, 530491, 530493, 530496, 530497, 530498, 530499, 530503, 530504, 530505, 530513, 530517, 530519, 530520, 530526, 530528, 530538, 530540, 530541, 530542, 530544, 530548, 530551, 530555, 530556, 530557, 530558, 530560, 530565, 530566, 530568, 530570, 530571, 530572, 530573, 530574, 530579, 530580, 530583, 530586, 530587, 530590, 530593, 530594, 530595

Incisive CT Power:

530294, 530307, 530329, 530338, 530342, 530349, 530350, 530357, 530358, 530363, 530368, 530369, 530370, 530372, 530374, 530378, 530384, 530388, 530389, 530404, 530409, 530419, 530420, 530431, 530432, 530435, 530452, 530456, 530461, 530464, 530466, 530470, 530475, 530476, 530480, 530486, 530489, 530492, 530494, 530502, 530506, 530507, 530508, 530509, 530510, 530515, 530523, 530524, 530527, 530529, 530535, 530543, 530545, 530547, 530549, 530559, 530561, 530562, 530563, 530564, 530569, 530575, 530577, 530578, 530581, 530584

Incisive CT Plus:

530320, 530332, 530408, 530430, 530437, 530449, 530474, 530521, 530533, 530537, 530550

特此公告。

飞利浦医疗（苏州）有限公司

日期：2023-12-29