Generic Name: Washer-disinfector For Flexible Endoscopes — Trade Name: Endoscope Washer-disinfector Espal+
- Recalling firm
- Name of Manufacturer/Distributor: Toyoei Kogyo Co., Ltd. — Address of Manufacturer/Distributor: 1-369 Shinma-hira, Kawada, Shinshiro City, Aichi Prefecture — License Type: Type II Medical Device...
- Product
- Lot: ESPP00005、ESPP00006、ESPP00007、ESPP00008、ESPP00009、ESPP00010、ESPP00012、ESPP00014、ESPP00015、 ESPP00016、ESPP00017、ESPP00019、ESPP00020、ESPP00021、ESPP00022、ESPP00023、ESPP00024、ESPP00025、 ESPP00026、ESPP00027、ESPP00028、ESPP00029、ESPP00030、ESPP00032、ESPP00033、ESPP00034、ESPP00035、 ESPP00036、ESPP00038、ESPP00040、ESPP00043、ESPP00045、ESPP00046、ESPP00047、ESPP00048、ESPP00049、 ESPP00050、ESPP00051、ESPP00052、ESPP00053、ESPP00054、ESPP00055、ESPP00057、ESPP00058、ESPP00059、 ESPP00060、ESPP00061、ESPP00063、ESPP00064、ESPP00066、ESPP00067、ESPP00068、ESPP00069、ESPP00070、...
- Reason
- This product was originally designed to display an error message when no disinfectant solution (undiluted) is drawn in; however, since it lacked a detection function to identify instances where the drawn-in volume was below the specified amount, we have decided to modify the product to ensure that an error is reliably displayed.
- 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/599800d5-c6be-4d27-b6b4-1c1913f42b30