Philips North America LLC recalls Philips DXR System

Potential for collimator to fall as a result of incorrect installation.

Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

Consignees received an URGENT MEDICAL DEVICE CORRECTION NOTICE dated 3/7/25. The notice instructs customers of safety precautions to take during scan preparation to ensure devices are fit for use. If consignees notice that the laser from the collimator or crosshairs of the collimator's light field is not able to align with the silkscreen on the front cover of the detector, consignees are to immediately stop use and call their Philips representative. The provided notice is to be posted near affected systems and circulated to all device users. Philips will reach out to consignees to schedule an inspection of devices by field service engineers. Engineers may also replace the collimator, if necessary. Consignees with questions are to call Philips Customer Care Solutions Center at 1-800-722-9377 from Monday through Friday (8:00 AM to 8:00 PM EST).

• FDA enforcement recordOfficial FDA database entry for Z-1554-2025
• FDA 510(k) clearance · K141381The device's official FDA premarket clearance record
• FDA 510(k) clearance · K201640The device's official FDA premarket clearance record
• FDA device classification · KPROfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips North America LlcSearch 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.