CLASS I ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report

Magnetom Connectom.X recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Magnetom Connectom.X, distributed nationwide in the US. The recall was initiated on 28 Aug 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel Number: 11371480. UDI Numbers: N/A. Serial Numbers: 237551.

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2657-2025
FDA event ID: 97530
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class I
Status: Ongoing
Recall initiated: 28 Aug 2025
FDA classified: 30 Sep 2025
Reported: 8 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

28 Aug 2025	Recall initiated by company
30 Sep 2025	Classified by FDA	+33 days
8 Oct 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

MAGNETOM Connectom.X. Model Number: 11371480.

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Is Magnetom Connectom.X recalled?

Yes. Siemens Medical Solutions USA recalled Magnetom Connectom.X on 28 Aug 2025. The recall is Class I and its status is Ongoing. Recall number Z-2657-2025.

Why was it recalled?

Which lots are affected?

Model Number: 11371480. UDI Numbers: N/A. Serial Numbers: 237551.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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