—#217639

Product

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193215
Affected lot / code info: MR systems with SW version R11.1 and R12.1. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669.

Why it was recalled

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Root cause (FDA determination)

Software design

Action the firm took

Philips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620).

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.

Timeline

Recall initiated: 2025-12-03
Posted by FDA: 2026-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217639. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.