—#213879

Product

Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Model Numbers: (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42023, 42024, 42078, 42375, 42402, 42408, 71348, 85675, 85687, 85694, 85705, (2) 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85684, 85688, 85690, 85695, 85697, 85699, 85708;

Why it was recalled

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Root cause (FDA determination)

Software design

Action the firm took

On May 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users You may continue to use your system(s) in accordance with the intended use. A. To avoid the potential issue of an incorrect cross reference line in MobiView generated images, use the same voxel size and field of view across all station scans. B. Do not use cross reference line functionality in box mode, all slices mode, or 3D mode. Use the cross reference line functionality in single slice mode. Circulate this notice to all users of this device so that they are aware of the issues and associated hazard/harm. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Please complete and return the attached response form to Philips MR promptly and no later than 30 days from receipt of this letter via email to: Philips.Recall@Philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction letter, understanding of the issues, and required actions to be taken. 5. Actions planned by Philips MR to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues (reference FCO78100566, FCO78100584, FCO78100585, FCO78100620, FCO78100621). If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax. For more information, pl

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.

Timeline

Recall initiated: 2025-05-13
Posted by FDA: 2025-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213879. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.