Generic Name: Control Unit For A Percutaneous Central Venous Temperature Regulation Device — Trade Name: Thermoguard Hq Console

Recalling firm: Name of Manufacturer and Distributor: Asahi Kasei Zol Medical Co., Ltd. — Address of Manufacturer and Distributor: Kowa Nishi-Shimbashi Building, 2-1-1 Nishi-Shimbashi, Minato-ku, Tokyo — Type of...
Product: Lot: 対象品：本品のコンソールカタログ番号：8700-001106-207 対象シリアル番号： TGHQ20047、TGHQ20048、TGHQ20049、TGHQ20050、TGHQ20051、TGHQ20052、 TGHQ20053、TGHQ20055、TGHQ20056、TGHQ20057、TGHQ20058、TGHQ20059、 TGHQ20060、TGHQ20076、TGHQ20077、TGHQ20078、TGHQ20079、TGHQ20080、 TGHQ20081、TGHQ20082、TGHQ20084、TGHQ20086、TGHQ20087、TGHQ20088、 TGHQ20089、TGHQ20090、TGHQ20091、TGHQ20092、TGHQ20093、TGHQ20094、 TGHQ20120、TGHQ20124、TGHQ20125、TGHQ20128、TGHQ20129、TGHQ20146、 TGHQ20148、TGHQ20149、TGHQ20204、TGHQ20205、TGHQ20206、TGHQ20207、 TGHQ20208、TGHQ20209、TGHQ20215、TGHQ20216、TGHQ20217、TGHQ20220、...
Reason: This product is equipped with a 6.3-amp fuse to protect the device from overcurrent, and two spare fuses are included in the package. Following an internal investigation, we have determined that the two spare fuses included with units bearing specific serial numbers are 1.0-amp fuses rather than 6.3-amp fuses. Therefore, we are conducting a voluntary recall of the affected products (see attached list) to replace them with the correct fuses. Please note that this voluntary recall applies only to the spare fuses; the 6.3-amp fuses installed in the equipment at the time of shipment from our...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/a5e1963f-75be-4f8d-8724-8cba589c64af