FDAClass II · Medical device · Recalled June 17, 2026

DigitalDiagnost C90 Flex/Value/Chest/ER recall — Philips North America Llc

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2354-2026
Brand: Philips North America
Classification: Class II
Units affected: 1 unit
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

DigitalDiagnost C90 Flex/Value/Chest/ER

Companies & origin

Recalling firm location: Cambridge, MA, United States
Firm address: 222 Jacobs St, N/A, 02141-2289

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: 712035. UDI: (01)00884838090705(21)24861049. Lot Code: 24861049.
Distribution: US distribution to California.
Firm notified the public via: Letter
FDA event ID: 98940
Recall initiated: May 1, 2026
FDA classified: June 5, 2026
FDA report date: June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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