Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Medical Solutions USA
- Product type
- MRI Magnet/System
- Model numbers
- Model 11371480
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 28, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The MAGNETOM Connectom.X is a high-field MRI system used in advanced clinical imaging and research settings.
Why This Is Dangerous
Ice blockage in the venting system could prevent helium from escaping during a quench, risking rupture of the containment and potential helium release.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
High-risk device recall with potential room contamination and safety concerns for patients and staff; replacement or repair timing will influence clinical operations.
Practical Guidance
How to identify if yours is affected
- Identify the model 11371480 and serial number 237551 on the device plaque.
- Verify recall status via FDA enforcement page linked in the notice.
- Check with the healthcare facility's biomedical engineering department for remediation steps.
Where to find product info
FDA enforcement page linked in the recall notice and facility recall communications.
What timeline to expect
Timeline provided by Siemens will guide refunds or replacements; no date specified in the data.
If the manufacturer is unresponsive
- Escalate to hospital administration or patient safety officer.
- File a report with the FDA if the issue is not resolved promptly.
How to prevent similar issues
- Confirm future MRI systems have enhanced venting redundancy.
- Maintain inventory of contact channels for rapid recall responses.
Documentation advice
Keep copy of recall notice, serial number, and all communications with Siemens and hospital Biomedical Engineering.
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Product Details
Brand: Siemens Medical Solutions USA. Product: MAGNETOM Connectom.X MRI system. Model Number: 11371480. Serial Numbers: 237551. Distribution: Worldwide. Recall date: 2025-08-28. Status: ACTIVE.
Reported Incidents
No specific injuries or incidents are detailed in the provided data.
Key Facts
- High hazard level
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Safety Guide
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