Philips North America LLC recalls DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.

Philips Medical notified the single consignee on about 05/01/2026 via mailed letter. The consignee was notified of the issue, potential risk, and instructed to Stop using the Wall Stand VS2 immediately to ensure patient and user safety while Philips provides the Seismic Bucky Unit 2 (BU2) Skyplate kit, do not attempt to inspect, adjust, or install any mechanical components of the Wall Stand yourself, circulate this Urgent Medical Device Correction letter to all users of this device so that they are aware of the issue and associated impact, and complete and return the provided response form. A Philips representative will contact the consignee to schedule a time for a Field Service Engineer (FSE) to visit the site to install a hardware correction.

• FDA enforcement recordOfficial FDA database entry for Z-2354-2026
• FDA 510(k) clearance · K202564The device's official FDA premarket clearance record
• FDA device classification · MQBOfficial 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.