Recall Z-2354-2026 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips North America Llc
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
| Date | Jun 5, 2026 (initiated May 1, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 1 unit |
| Distribution | US distribution to California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202564 | DigitalDiagnost C90 Philips Medical Systems Dmc GmbH, Sep 30, 2020 |