Biograph mMR. Model Number: 10433372 recallZ-2654-2025 · Siemens Medical Solutions USA, Inc · initiated Aug 28, 2025

Why it was recalled

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens Healthcare notified consignees on about 08/28/2025 via letter. Consignees were informed that Siemens Customer Service Organization will conduct an inspection of affected units to address the issue. If customers identify issues, they are cautioned to not reboot the system, to call their local Siemens Healthineers service organization, and grant access to the system. Siemens will inspect devices and perform a correction, if needed. Consignees were also instructed to ensure all users or customers are notified of the issue and to maintain the Customer Safety Advisory Notice. Consignees were also requested to confirm receipt and acknowledgement of the notification. Siemens expanded the recall and notified consignees on about 10/01/2025 via letter. These notifications included the same information as initially sent to consignees. A follow up communication was sent to consignees on about 10/15/2025 via letter. This informed users of further details and additional necessary safety actions. If a specific "Magnent Supervision" error message appears on the host computer, no further scans can be performed, and you are requested to: not reboot the system, remove the patient from the system, lock/secure all access to the scanning room with the system remaining energized at field, post a DO NOT USE notice on or near the device, and call the Siemens Healthineers service organization. In addition, Siemens reminded users that the Magnet Stop button is only intended for emergencies. DO NOT initiate a manual quench of the magnet unless there is an emergency. Ensure all designated emergency exit routes remain unobstructed and are marked. Consignees were also instructed to ensure all users or customers are notified of the issue, to maintain the Customer Safety Advisory Notice is retained in product related records, to confirm receipt and acknowledgement of the notification, and if the affected system is no longer in the consignee's possession, notify the new owner. ***Updat

Recall details

Recall number

Z-2654-2025

Status

Open, Classified

Initiated by the company

Aug 28, 2025

Posted by the FDA

Sep 30, 2025

Recalling firm

Siemens Medical Solutions USA, Inc

Quantity

27 units

Product code

OUO

FDA submissions

K200213

Distribution

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

Product description

Biograph mMR. Model Number: 10433372.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• MAGNETOM Vida Fit 11410481

  Siemens Healthcare GmbH · System, nuclear magnetic resonance spectroscopic
  3 recalls1 report
• Biograph mMR 10433372

  Siemens Healthcare GmbH · Tomographic imager combining emission computed tomography with nuclear magnetic resonance
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 97530).

• Z-2655-2025 · Open, Classified
  BIOGRAPH One (DE). Model Number: 11689172.
• Z-2656-2025 · Open, Classified
  MAGNETOM Cima.X (DE). Model Number: 11647158.
• Z-2658-2025 · Open, Classified
  MAGNETOM Lumina (DE). Model Number: 11344916.
• Z-2659-2025 · Open, Classified
  MAGNETOM Prisma. Model Number: 10849582.
• Z-2660-2025 · Open, Classified
  MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
• Z-2661-2025 · Open, Classified
  MAGNETOM Skyra fit. Model Number: 10849580.
• Z-2662-2025 · Open, Classified
  MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
• Z-2663-2025 · Open, Classified
  MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
• Z-2664-2025 · Open, Classified
  MAGNETOM Verio. Model Number: 10276755.
• Z-2665-2025 · Open, Classified
  MAGNETOM Verio Dot. Model Number: 10684333.
• Z-2666-2025 · Open, Classified
  MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
• Z-2667-2025 · Open, Classified
  MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
• Z-2668-2025 · Open, Classified
  MAGNETOM Vida Fit. Model Number: 11410481.