Siemens MAGNETOM Cima.X MRI Recall: 9 Units Worldwide (2025)

How to identify if yours is affected

1. Check model number 11647158 and all listed UDIs/serial numbers.
2. Review asset records for the nine units distributed worldwide.
3. Compare device identifiers to the recall list provided by Siemens and the FDA notice.

Where to find product info

Look for model number, UDI, and serial numbers on the device label and documentation.

What timeline to expect

Recall remedies and timelines will be provided by Siemens to affected facilities. Expect weeks to months for action.

If the manufacturer is unresponsive

• Document all communications with the manufacturer.
• Engage hospital risk management and regulatory channels.
• Escalate to FDA recall contacts if the vendor is unresponsive.

How to prevent similar issues

• Establish a routine recall monitoring process for high-value medical devices.
• Verify venting system maintenance protocols and IQ/OQ procedures.
• Ensure asset tracking with up-to-date serials and UDIs.

Documentation advice

Keep the recall notice, device identifiers, service records, and all correspondence with the manufacturer.