Generic Name: Washer For Decontaminating Medical Devices — Trade Name: Getinge Aquadis 56 Series

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 — License Type:...
Product: Lot: 出荷数量：76台出荷時期：令和4年10月18日〜令和7年5月30日対象型式：56A-001 56M-001 対象シリアル： WAA105877 WAA105965 WAA107148 WAA107232 WAA107267 WAA107307 WAA107314 WAA107330 WAA107360 WAA107418 WAA108067 WAA108136 WAA108137 WAA108161 WAA108170 WAA108217 WAA108409 WAA108479 WAA108499 WAA108500 WAA108653 WAA108743 WAA108745 WAA108746 WAA108863 WAA108864 WAA109187 WAA109199 WAA109200 WAA109207 WAA109209 WAA109269 WAA109278 WAA109285 WAA109305 WAA109309 WAA109314 WAA109327 WAA109497 WAA109501 WAA109507 WAA109565 WAA110062 WAA110075 WAA110084 WAA110104 WAA110163 WAA110208 WAA110226 WAA110302 WAA110361 WAA110643...
Reason: Upon receiving reports of product malfunctions, the overseas manufacturer conducted an investigation and confirmed that in some units, the circulation pump starts earlier than expected, causing brief periods of dry running. It was determined that this issue was caused by a flaw in a specific program within a component installed in the product. Consequently, the overseas manufacturer has conducted operational checks on all affected serial-numbered products and, where operation resulting from the program flaw was confirmed, has initiated a voluntary recall to replace the affected components...
Classification: Class III
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/ce01baaf-2464-4893-beb8-ab6e01306731