Philips North America recalls Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 78135…

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form.

• FDA enforcement recordOfficial FDA database entry for Z-1961-2026
• FDA 510(k) clearance · K193215The device's official FDA premarket clearance record
• FDA 510(k) clearance · K213583The device's official FDA premarket clearance record
• FDA 510(k) clearance · K223458The device's official FDA premarket clearance record
• FDA 510(k) clearance · K251397The device's official FDA premarket clearance record
• FDA 510(k) clearance · K251808The device's official FDA premarket clearance record
• FDA device classification · LNHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1000The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips North AmericaSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.