Recall Z-2354-2026— Philips North America Llc

Name: FDA recall Z-2354-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-01

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2026-05-01. It names one FDA 510(k) clearance: K202564. Product: DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.. 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2026-05-01
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K202564 — DigitalDiagnost C90Philips Medical Systems Dmc GmbH·cleared 2020-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.