General Name: Superconducting Magnet-type Whole-body Mri System — Trade Name: (1) Mri System Vantage Titan 3t Mrt-3010(*) — (2) Mri System Vantage Galan 3t Mrt-3020

Recalling firm

Name of Manufacturer/Distributor: Canon Medical Systems Corporation — Address of Manufacturer/Distributor: 1385 Shimoishigami, Otawara City, Tochigi Prefecture — Type of License: Class I Medical...

Product

Lot: １）形式名： MRT-3010(*) Ser.No : J5A1052001,J5A1052002,J5A1072003,J5A10Y2006,J5A1152008,J5B11X2010,J5B11X2011 J5B11Z2013,J5B1212014,J5C1222016,J5C1222017,J5C1232018,J5C1252020,J5C1252021 J5C1292025,J5C12X2026,J5C12X2028,J5C12Z2029,J5D1312030,J5D1312031,J5D1322032 J5D1332034,J5E1372035,J5E1382036,J5E13Z2040,J5E1472042,J5E1492044,J5F1522045 J5F1522047,J5F1562049,J5F1562050,J5F15X2053,J5F15X2054,J5G15Z2055,J5G15Z2056 J5G1612057,J5G1612058,J5G1652059,J7A15X2001,J7A1632003,J7A1722004 数量 : 41台(*) 出荷時期:平成 22年 6月〜平成 29年 2月(*) ２）形式名 : MRT-3020 Ser.No :...

Reason

It has been confirmed that ice formation may occasionally occur in the exhaust system of superconducting magnets. If a quench occurs under these conditions, helium gas may not be vented 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 containment vessel to rupture, resulting in a helium leak into the scan chamber. Although such an incident is considered unlikely, the manufacturer has decided to inspect the exhaust system as a precautionary measure and make necessary...

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/25ed2add-215b-4d30-b641-9c9c56ec855b