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Open, Classified

DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

FDA Recall Z-2354-2026 · Posted 2026-06-05

Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeMQB
Date Initiated2026-05-01
Product Quantity1 unit

Reason for Recall

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.

Firm 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 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.

Root Cause

Device Design

Distribution Pattern

US distribution to California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020-09-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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