Generic Name: Heated Humidifier — Brand Name: Inspired Flow
- Recalling firm
- Name of Manufacturer/Distributor: Inspired Medical Japan Co., Ltd. — Address of Manufacturer/Distributor: Nakagawa Building, 3-31-1 Yushima, Bunkyo-ku, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: 回収対象：2019年〜2023年出荷分（1102台） 1852040013,2045100001,2045100002,2045100003,2045100004 2045100005,2045100006,2045100007,2045100008,2045100009 2045100010,2045100011,2045100012,2045100013,2045100014 2045100015,2045100016,2045100017,2045100018,2045100019 2045100020,2045100021,2045100022,2045100023,2045100024 2045100025,2045100026,2045100027,2045100028,2045100029 2045100030,2045100031,2045100032,2045100033,2045100034 2045100035,2045100036,2045100037,2045100038,2045100039 2045100040,2045100041,2045100042,2045100043,2045100044 2045100045,2045100046,2045100047,2045100048,2045100049...
- Reason
- An incident occurred with the Inspired Flow (hereinafter referred to as "this device") in which the device unexpectedly stopped operating during treatment. Following an investigation by the overseas manufacturer, it was determined that, although this is an extremely rare occurrence, the incident could be caused by the influence of incidental noise; therefore, we have decided to conduct a voluntary recall.
- 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/456d456e-99a5-4053-80a2-bd28a169e221