Generic Name: Multi-parameter Monitor With Key Parameters — Trade Names: (1) Carescape Bedside Monitor Series — (2) Carescape One Monitor — (3) B105 B125 Vital Signs Monitor

Recalling firm: Name of Manufacturer and Distributor: GE Healthcare Japan Co., Ltd. — Address of Manufacturer and Distributor: 4-7-127 Asahigaoka, Hino City, Tokyo — License Type: Class I Medical Device...
Product: Lot: （1）CARESCAPE ベッドサイドモニタシリーズ製造番号： SNT25100008HA 数量：１台出荷時期：令和７年５月（2）CARESCAPE ONE モニター製造番号： SV925110011HA、SV925110012HA、SV925110022HA、SV925150028HA、SV925150029HA、SV925150030HA、 SV925150031HA、SV925150033HA、SV925150040HA、SV925150047HA、SV925150048HA、SV925150049HA、 SV925150050HA、SV925150051HA、SV925200038HA、SV925200069HA、SV925220069HA、SV925220077HA 数量：１８台出荷時期：令和７年４月〜令和７年７月（3）B105 B125 生体情報モニタ製造番号： SV425090018WA、SV425120081WA、SV425230378WA、SV425230379WA、SV425270512WA、SV525040071WA、 SV525040072WA、SV525040073WA、SV525040074WA、SV525090010WA、SV525140127WA、SV525160314WA、...
Reason: According to a report from the manufacturer, we have learned that an issue with a specific battery (FLEX-3S2P) used in this device may cause the power supply to fail during battery operation, potentially resulting in a loss of monitoring. Therefore, based on information from the manufacturer, we are issuing this notice to alert customers and will carry out a repair program to replace the batteries with ones that have been modified to resolve the issue.
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/120b0651-fd9f-42d6-8275-62fd8b214649