Generic Name: Anesthesia System — Trade Name: A9 Anesthesia System
- Recalling firm
- Name of Manufacturer and Distributor: Izumi Kogyo Co., Ltd. — Address of Manufacturer and Distributor: 2-11-1 Hamakawado, Kasukabe City, Saitama Prefecture — License Type: Class I Medical Device...
- Product
- Lot: 対象製造番号： Ａ９ 麻酔システム（V90セボフルラン気化器） AG4-38001330(AG4G37002399) AG4-38001331(AG4G37002400) AG4-38001332(AG4G37002395) AG4-38001333(AG4G37002392) AG4-38001334(AG4G37002385) AG4-38001335(AG4G37002396) AG4-38001336(AG4G37002397) AG4-38001337(AG4G37002398) AG4-38001338(AG4G37002379) AG4-38001339(AG4G37002378) AG4-38001340(AG4G37002394) AG4-38001341(AG4G37002393) FX7-3B000112(AG4H3C003012) FX7-3B000113(AG4H3C003011) FX7-3B000114(AG4H3C003010) FX7-3B000115(AG4H3C003013) FX7-3B000116(AG4H44003699) FX7-44000473(AG4H3C003014) FX7-44000474(AG4H44003700) 出荷台数：１９台...
- Reason
- We have received notification from the foreign manufacturer of this product that it has been confirmed that, when connecting an anesthetic bottle to the anesthetic inlet of the V90 sevoflurane vaporizer installed in the A9 anesthesia system, repeatedly applying excessive downward force can damage the interior of the inlet, causing vaporized anesthetic gas to leak into the atmosphere through the damaged area. Consequently, we were informed that the part would be replaced with a reinforced version to improve durability. Therefore, we have decided to notify the medical institutions to which...
- 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/7dc5e2b1-296d-46a1-8cdc-9913383d01e6