Generic Name: Particle Beam Therapy System — Trade Names: (1) Probeat-rt Proton Therapy System — (2) Probeat-cr Proton Therapy System — (3) Probeat-m1 Proton Therapy System
Recall Summary Three Hitachi High-Tech proton therapy systems used to treat solid cancers and brain tumors are being recalled due to a software issue in the patient positioning system. When manually selecting images during a specific positioning mode, the system may not properly position the patient, though following standard operating procedures prevents this problem and positioning checks in other modes would catch any errors. A software update will fix the issue, no patient injuries have been reported, and the company considers the risk of serious harm to be minimal.
- 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)陽子線治療システム PROBEAT-RT PTRT-01 出荷数量：1台 出荷時期：平成26年2月 (2)陽子線治療システム PROBEAT-CR PTCR-01 出荷数量：1台 出荷時期：平成31年3月 (3)陽子線治療システム PROBEAT-M1 PTM1-01 出荷数量：1台 出荷時期：令和4年1月. Use: 患者体内の固形がん及び脳腫瘍に対して、高エネルギー陽子線を照射する陽子線治療システムです。. Health hazards: 本事象による位置ズレは、手順通りに操作を行えば発生しません。 また、別の位置決めモードでの位置決め確認も行うため、事象が発生した場合でも位置ズレに気付くことが可能 ですので、重篤な健康被害が発生する可能性はまず考えられません。 なお、今回の事例による健康被害発生の連絡は受けておりません。
- Reason
- We have determined that manually selecting an image while transferring images in a specific positioning mode using the patient positioning assistance system for this medical device can prevent proper positioning; therefore, we have decided to implement a corrective measure in the form of a software update.
- 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/a72c4e9e-e685-463f-9b1d-e9bfd92eaa37