PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Philips notified consignees on about 06/17/2026 via letter sent certified mail titled, URGENT Medical Device Correction. Consignees were instructed to circulate the notification letter to all users of the system for awareness and to follow the instructions. In the case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available. Note: Transversal stand movements (2) are only available for ceiling-mounted systems with the FlexMove option. For floor-mounted systems, only rotational (3) stand movements remain available. The table longitudinal position (4) can be adjusted manually, when the table is not tilted. Additionally, consignees were instructed to provide a copy of the notification letter to any organizations to which affected units have been transferred to, to keep the notification letter with system documentation until the correction is complete and complete and return the provided response form. Philips will inspect all affected systems and replace HDDs that are not according to the specifications, as well as correct configurations where different HDD types are used within a single system. Philips expects to start the implementation of this correction in September 2026.

• FDA enforcement recordOfficial FDA database entry for Z-2893-2026
• FDA 510(k) clearance · K102005The device's official FDA premarket clearance record
• FDA 510(k) clearance · K130638The device's official FDA premarket clearance record
• FDA 510(k) clearance · K130842The device's official FDA premarket clearance record
• FDA 510(k) clearance · K133292The device's official FDA premarket clearance record
• FDA 510(k) clearance · K141979The device's official FDA premarket clearance record
• FDA 510(k) clearance · K161563The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search 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.