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
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 System (MAGNETOM Skyra)
- Model numbers
- Model Number: 10432915, UDI: 01 04056869006703 21 145760, (01)04056869006703(21)45549, (01)04056869006703(21)146110, (01)04056869006703(21)146093, (01)04056869006703(21)146082, (01)04056869006703(21)45124, (01)04056869006703(21)145390 +13 more
- 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
MAGNETOM Skyra is a high-field MRI system used in hospitals for diagnostic imaging. It offers advanced imaging capabilities and is installed in clinical settings. Typical use includes brain, spinal, and body imaging.
Why This Is Dangerous
Ice within the venting system can block helium venting during safety venting events called quenches. This may cause pressure buildup and rupture helium containment, risking a helium leak into the scanning room.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may face downtime during service, potential safety concerns for staff and patients, and possible remediation costs.
Practical Guidance
How to identify if yours is affected
- Identify model 10432915 and verify against UDI numbers.
- Cross-check with listed 510(k) numbers.
- Confirm product serials and date codes match recall records.
Where to find product info
Refer to the FDA recall page and Siemens notice for exact identifiers like UDI and model numbers.
What timeline to expect
Remediation timelines vary by facility, commonly 4-8 weeks for service arrangements.
If the manufacturer is unresponsive
- Document every contact attempt.
- Escalate to regional Siemens service manager or corporate safety office.
- Consider filing a complaint with the FDA if service delays occur.
How to prevent similar issues
- Schedule regular venting system inspections.
Documentation advice
Maintain copies of all correspondence, service orders, and equipment status before and after remediation.
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Product Details
Model Number: 10432915. 510(k) numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560. Quantity: 182 units. Distribution: Worldwide, including US and many countries listed.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Wide distribution including US and 100+ countries
- Hazard: ice blockage in magnet venting system could cause helium leak during quench
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Safety Guide
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