Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Magnetic Resonance Imaging (MRI) System
- Model numbers
- Model Number: 11410481
- Sold at
- Multiple Retailers
- 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 Vida Fit MRI system is used for medical imaging in various healthcare settings. Facilities purchase it for advanced diagnostic capabilities in examining patient conditions.
Why This Is Dangerous
The device may allow ice to form, obstructing proper helium venting. If the helium containment system ruptures due to pressure, it can lead to a dangerous leak.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This potential hazard poses significant risks for medical facilities, requiring immediate action to ensure patient and staff safety.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device.
- Verify against the recalled model number: MAGNETOM Vida Fit, model number: 11410481.
- Check for UDI numbers listed.
Where to find product info
The model number and UDI numbers are usually found on the device's nameplate or user manual.
What timeline to expect
Expect a timeline of 4-6 weeks to process refunds or replacements, depending on the manufacturer's response.
If the manufacturer is unresponsive
- Contact Siemens Medical Solutions directly again.
- Document all correspondence and attempt other communication methods if necessary.
How to prevent similar issues
- After the recall, ensure future purchases include ventilation checks.
- Look for safety certifications when selecting medical devices.
Documentation advice
Document all relevant information, including model numbers, recall notices, and communications with customer service.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: MAGNETOM Vida Fit 11410481
- Risk of helium leak from pressure build-up
- No reported injuries or incidents
- Stop using device immediately for safety
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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