Generic Name: General-purpose Ecg Monitor — Trade Name: Ecg Monitor (with Analysis Function) Mac Vu360
Recall Summary GE Healthcare is recalling three MAC VU360 ECG monitors (used to diagnose heart conditions) because the acquisition module holder may not secure properly, causing the cable to bend excessively and overheat. Prolonged contact with an overheated cable could cause burns to users, though no injuries have been reported to date. GE Healthcare will replace the acquisition module holder with a modified version.
- 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: 製造番号 ： VU223090200SA、VU223090204SA、VU223090217SA 数量 ： ３台 出荷時期 ： 令和５年３月. Use: 四肢誘導、及び胸部誘導を含む最低 12 誘導の心電図検査、およびベクトル心電図の記録又は計測を行い、心臓 疾患の診断に用いる装置です。. Health hazards: 本問題によって、過熱したケーブルに長時間接触した場合、使用者の火傷につながるおそれがあります。しかし ながら、装置の使用に際しては、医療従事者により常に監視されており、異常が発生した場合においても直ちに 適切な処置をとれることから、本事象により患者へ重篤な健康被害が発生することは無いと考えております。 なお、これまでに本事象による健康被害の発生は報告されておりません。
- Reason
- According to a report from the manufacturer, it has been determined that if the acquisition module installed in this device is not properly secured in the acquisition module holder, the acquisition trunk cable may become excessively bent or worn. If this issue goes unnoticed and the device continues to be used, the acquisition trunk cable may overheat. Prolonged contact with an overheated cable could result in burns to the skin. Therefore, based on information from the manufacturer, we are issuing this notice to alert customers and will perform a repair to replace the acquisition module...
- 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/01f13fcc-893b-4ba7-88c4-22afeb88896a