Generic Name: Anesthesia System — Trade Name: Dräger General Anesthesia Machine Atlan Series
- Recalling firm
- Name of Manufacturer/Distributor: Dräger Japan Co., Ltd. — Address of Manufacturer/Distributor: Meguro Tokyu Building, 2-13-17 Kamiosaki, Shinagawa-ku, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: 製造番号：ASUA-0431, ASUA-0457, ASUB-0041, ASUB-0043, ASUB-0044, ASUB-0046, ASUB-0048, ASUB-0057, ASUB-0058, ASUB-0063, ASUB-0064, ASUB-0066, ASUB-0067, ASUB-0069, ASUB-0128, ASUB-0129, ASUB-0130, ASUB-0189, ASUB-0190, ASUB-0191, ASUB-0246, ASUB-0247, ASUB-0252, ASUB-0253, ASUB-0254, ASUC-0002, ASUC-0003, ASUC-0061, ASUC-0062, ASUC-0063, ASUC-0250, ASUC-0297, ASUC-0298, ASUC-0318, ASUD-0045, ASUD-0288, ASUD-0289, ASUD-0290, ASUD-0291 数量：39台 出荷時期：令和7年3月5日〜令和7年5月19日(*). Use: 本品は、成人、小児、新生児に対し、酸素、笑気ガス、空気、麻酔剤を混合して供給し、持続的に吸入麻酔を行 うための装置である。. Health hazards:...
- Reason
- In post-marketing surveillance activities conducted by the overseas manufacturer, cases were reported in which malfunctions of the piston ventilator occurred prior to use (during testing) of the Dräger Atlan series general anesthesia machines (hereinafter referred to as “the affected devices”), or in which mechanical ventilation became impossible during use. As a result of an investigation by the overseas manufacturer, it was confirmed that these incidents were caused by the temporary introduction of foreign matter during the manufacturing process. Consequently, we have decided to provide...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/d5a1aa17-5875-46d5-ad31-6e904dfaaf67