Generic Name: Control Unit For Water Pad Heating System — Trade Name: Arctic Sun Stat Body Temperature Management System
- Recalling firm
- Name of Manufacturer/Distributor: Medicon Co., Ltd. — Address of Manufacturer/Distributor: 1-13-22 Sonezaki Shinchi, Kita-ku, Osaka City, Osaka Prefecture — License Type: Class I Medical Device...
- Product
- Lot: カタログ番号：600020 製造番号：DYJTAL017、DYJVAL055、DYJTAL020、DYJTAL023、DYJVAL054、DYJVAL052、DYJVAL051、DYJWAL007、DY JYAL012、DYJWAL003、DYJVAL058、DYJWAL011、DYJWAL010、DYJYAL035、DYJYAL033、DYJWAL005、DYJTAL018、DYJ TAL019、DYJTAL021、DYJTAL022、DYJTAL024、DYJVAL053、DYJVAL056、DYJVAL057、DYJVAL059、DYJVAL060、DYJW AL001、DYJWAL002、DYJWAL004、DYJWAL006、DYJWAL008、DYJWAL009、DYJYAL031、DYJYAL032、DYJYAL034、DYJYA L036、DYJYAL038、DYJVAL061、DYJYAL037、DYJYAL039、DYJYAL040、DYJYAL041、DYJZAL022 出荷数量：43台 出荷期間：令和6年11月22日〜令和7年7月2日. Use: 本品は、患者の体を冷却又は加温するために使用する。心停止・心拍再開後の成人患者には、体温管理（体温管 理療法）にも使用する。. Health hazards:...
- Reason
- The system is designed such that Alert 113, “Reduced Water Temperature Control Capability,” is triggered when the water temperature fails to reach the target temperature during normal temperature maintenance or during cooling/heating operations. However, an investigation by the manufacturer revealed that, although infrequent, there are instances where this alert does not occur; therefore, we have decided to implement a voluntary modification. Note that this alert is designed to trigger when the system detects that the water temperature has not been accurately controlled over the most...
- 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/827d603e-f17b-40f0-bcf2-dc84f1560d77