Generic Name: (1) To (4) Particle Therapy Systems, (5) Linear Accelerator System — Trade Name: (1) Particle Therapy System (carbon Ion/proton Type) — (2) Particle Therapy System Melthea (proton Type) — (3) Particle Therapy System Melthea (carbon Ion Type) — (4) Particle Therapy System Melthea V — (5) Linear Accelerator System Mhi-tm2000

Recalling firm: Name of Manufacturer and Distributor: Hitachi High-Tech, Inc. — Address of Manufacturer and Distributor: 1-17-1 Toranomon, Minato-ku, Tokyo — Type of License: Class I Medical Device Manufacturer...
Product: Lot: (1)粒子線治療装置（炭素イオン／陽子タイプ） MELTHEA-CH-01 出荷数量：1台出荷時期：平成14年11月 (2)粒子線治療装置 MELTHEA（陽子タイプ） 03HMPS01001,05HDSH01001,07HLJ501001,08HUMS01001 出荷数量：4台出荷時期：平成15年7月〜平成23年3月 (3)粒子線治療装置 MELTHEA（炭素イオンタイプ） 07HARC03001,10JDHA01001 出荷数量：2台出荷時期：平成22年5月〜平成25年8月 (4)粒子線治療装置 MELTHEA V 13FKYK01001,13FKZL01001,15FRAA01001 出荷数量：3台出荷時期：平成28年4月〜平成29年12月 (5)線形加速器システム MHI-TM2000 201904,202901,202902,202906,203904,203921,203922,203925, 203927,203928,203929,203930 出荷数量：12台出荷時期：平成21年4月〜平成28年12月. Use: (1)〜(4)固形がん及び脳腫瘍に対する粒子線治療 (5)高エネルギーのＸ線を用いて腫瘍等の放射線治療. Health hazards:...
Reason: A third-party product supplied as a component of the medical device in question (General name: Stationary diagnostic X-ray generator) If the contacts of the electromagnetic contactor (contactor) used inside the cabinet of the X-ray high-voltage unit become welded, it has been determined that current will continue to be supplied to the power circuit even if the unit’s power is turned off but the circuit breaker on the distribution panel is not turned off; as a result, it cannot be ruled out that the circuit may overheat and damage surrounding components. Therefore, we are providing this...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/bc39694f-7d10-4e86-9aca-5b768380776d