Generic Name: Anesthesia System — Trade Name: Flow-i Anesthesia System

Recalling firm: Name of Manufacturer and Distributor: Getinge Group Japan Co., Ltd. — Address of Manufacturer and Distributor: Sphere Tower Tennozu, 2-2-8 Higashi-Shinagawa, Shinagawa-ku, Tokyo — Type of License:...
Product: Lot: 対象は、FLOW-i麻酔システム、FLOW-i 麻酔システム (FLOW-c)、FLOW-i 麻酔システム (FLOW-e)の気化器ユニットの「セボフルラン気化器」製品番号：6682282 出荷数量：505台出荷時期：平成29年3月27日から令和6年12月13日シリアル番号 : 8557 8558 8559 8560 8561 8562 8565 8566 8607 8608 8609 8610 8611 8612 8613 8614 8615 8616 8617 8618 8619 8620 8621 8622 8623 8624 8625 8626 8653 8728 8729 8730 8732 8733 8735 8739 8740 8743 8744 8753 8756 8760 8766 8770 8771 8772 8773 8774 8775 8908 8909 8912 8957 8958 8960 8961 8962 8963 8964 8965 8966 8977 8978 8979 8980 8981 8982 8983 8984 8985 8986 9027 9028 9029 9030 9031 9032 9033 9035 9826 9827 9831 9833 9857 9859 9863 9864 9865 9950...
Reason: It has been determined that failure to comply with the following two points when using this product increases the risk of decomposition (deterioration) of the sevoflurane anesthetic, including the generation of hydrogen fluoride. 1) Do not store this product for more than 30 days while it contains sevoflurane anesthetic. 2) If the vaporizer is filled with anesthetic, operate it for clinical use or perform regular pre-use inspections. Do not leave the vaporizer idle for more than 30 days. Additionally, while the surface treatment method for this product’s agent container was changed in 2016...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/ee363053-eaaf-41c6-b333-bec50a1217ce