Generic Name: (1) To (6) Superconducting Magnet-type Whole-body Mri Systems; (7) Combined Mri-pet Systems — Trade Name: (1) Magnetom Vida — (2) Magnetom Cima X — (3) Magnetom Skyla — (4) Magnetom Spectra — (5) Magnetom Prisma — (6) Magnetom Berio
Recall Summary Siemens is recalling multiple models of MRI machines (MAGNETOM VIDA, CIMA X, SKYLA, Spectra, Prisma, and Berio) because ice can build up in the magnet exhaust system, which may prevent helium gas from venting properly during certain malfunctions. This pressure buildup could potentially cause the helium storage vessel to rupture and leak helium into the scan chamber. The recall affects approximately 190 to 500+ machines shipped between February 2018 and September 2025, depending on the model.
- Recalling firm
- Name of Manufacturer and Distributor: Siemens Healthcare K.K. — Address of Manufacturer and Distributor: Gate City Osaki West Tower, 1-11-1 Osaki, Shinagawa-ku, Tokyo — License Type: Class I...
- Product
- Lot: (1) 販売名 ： ＭＡＧＮＥＴＯＭ ヴィーダ 製造番号： 175802, 175828, 175902, 175940, 175943, 177094, 177630, 177633, 177637, 177642, 177644, 177648, 177663, 177677, 177678, 177685, 177687, 177692, 177700, 177709, 177719, 177721, 177726, 177740, 177747, 177753, 177754, 177759, 177760, 177761, 177767, 177774, 196204, 196207, 196208, 196219, 196232, 196269, 200020, 200022, 200052, 200069, 200071, 200088, 200127, 200159, 200165, 200184, 200188, 200202, 200211, 200228, 200236, 200243, 200245, 200246, 200251, 200253, 200255, 200256, 200257, 200259, 200261, 200262, 200268, 200270, 200271, 200280, 202018, 202090,...
- Reason
- It has been confirmed that ice blockages may occasionally occur in the magnet exhaust system. 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 storage vessel to rupture, potentially resulting in a helium leak into the scan chamber. Although such an occurrence is considered rare, the manufacturer has decided to inspect the exhaust system as a precautionary measure and make necessary corrections,...
- 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/56fe8ff0-a371-4905-a825-59c5d295e529