Generic Name: Superconducting Magnet-based Whole-body Mri System — Trade Name: Intraoperative Magnetic Resonance Imaging System Visius Surgical Theatre Imris Neuroiii-sv
Recall Summary One VISIUS Surgical Theatre IMRIS NeuroIII-SV MRI machine (manufactured December 2015, serial number 60111) is being recalled because ice can block the helium exhaust system, potentially causing pressure buildup that could rupture the helium storage vessel and leak gas into the imaging room. The manufacturer is conducting this voluntary recall to inspect and repair the exhaust system as a precaution, though no injuries have been reported in Japan from this issue.
- Recalling firm
- Name of Manufacturer and Distributor: Saikyo Biotech Co., Ltd. — Address of Manufacturer and Distributor: Gran Creste, 2-2-18 Sakai, Musashino City, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: 販売名：術中磁気共鳴画像診断システムVISIUS Surgical Theathre IMRIS NeuroIII-SV 製造番号：60111 数量：１台 装置引き渡し日：2015年12月16日. Use: 患者に関する磁気共鳴信号をコンピュータ処理し、再構成画像を診療のために提供すること。. Health hazards: クエンチ発生時にヘリウムガス排出システムが氷により閉塞していた場合、ガスがシステム内に充満し、圧力が 上昇することで、システムの破裂が生じる恐れがあります.破裂により撮影室内にヘリウムガスが漏洩し、窒息 の危険が及ぶ可能性があります。そのほか、ガスの急激な放出により低温やけどや機器の損傷が引き起される場 合があります。 しかしながら、当該医療機器の操作は添付文書および取扱説明書を熟知した医療従事者が行うため、異常が生じ た際は適切な処置を行うことができるため、本事象に起因して重篤な健康被害が発生する可能性はないと考えて おります。 なお、国内において本事象に起因した健康被害の発生は報告されておりません。
- Reason
- It has been confirmed that ice blockages may occasionally occur in the magnet’s helium exhaust system. If a quench occurs under these conditions, helium gas may not be exhausted through the exhaust path as designed, potentially causing the pressure inside the helium containment vessel to rise. This pressure increase could ultimately cause the helium storage vessel to rupture, resulting in a helium leak into the imaging chamber. Although such an occurrence is considered rare, the manufacturer has decided to inspect the exhaust system as a precautionary measure and implement corrective...
- 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/f6f66557-846c-4036-96fc-90169abd3cdf