Siemens MAGNETOM Skyra fit MRI Recalled for Ice Blockage Risk in 30 Units (2025)

How to identify if yours is affected

1. Identify model number 10849580.
2. Check listed UDIs to confirm if the device is affected.
3. Review the recall notice for any serial or lot identifiers.

Where to find product info

Serial numbers and UDIs can be found on the device label, in maintenance records, and on the FDA recall page.

What timeline to expect

Remediation timelines will be provided by Siemens and regulatory authorities; specifics will depend on institutional capacity.

If the manufacturer is unresponsive

• Document all communications.
• Escalate to regulatory authorities and hospital risk management.
• File a recall-related complaint with the FDA if needed.

How to prevent similar issues

• Require manufacturers to provide clear recall procedures before purchase.
• Confirm service and recall handling as part of procurement contracts.
• Maintain up-to-date inventory and recall readiness plans.

Documentation advice

Keep copies of the recall letter, the device UDIs, maintenance logs, and all recall communications.