Generic Name: Instrument Decontamination Washer — Product Name: Innowave Ultrasonic Washer Pcf Series
- Recalling firm
- Name of Manufacturer and Distributor: Steris Japan Co., Ltd. — Address of Manufacturer and Distributor: NK Shinwa Building, 1-5-1 Machi, Chiyoda-ku, Tokyo — License Type: Type II Medical Device...
- Product
- Lot: 対象機器のシリアルナンバー：12212313402/12212313403/12212313404/12212313405/12212313406/12212313407/ 12212313408/12212313409/12212313410/12212313401/12212313501/12212313502/12212313503/12212313504/1221 2313505/12212313506/12212313507/12212313508/12212313509/12212313510/02228313401/03228313402/02228312 901/02228312902/02228312903/02228312906/03228313403/03228313404/03228313405/02228312904/02228312905/ 08229512801 上記32台 出荷時期：2022年1月20日〜2024年1月9日. Use: 再使用可能な手術器具、麻酔器具等の手術用具の除染・消毒のために用いる。. Health hazards: 当該事象が発生した場合、装置が正常に作動しない等の症状により、被洗浄物が適切に洗浄されないおそれがあ...
- Reason
- This is because there have been instances where the device stopped operating and became inoperable due to a malfunction in the part of the ultrasonic transmitter board used inside the device that controls communication.
- 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/ac20b00d-5f0b-4c9f-836b-8231524e02ed