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FUKUDA DENSHI

FUKUDA DENSHI CO.,LTD. · Model FSD-64G · UDI-DI 04538612229800

DSI

510(k) clearances

33,370

Adverse events (505 deaths)

Recalls

118

Facilities

Recalls

Date	Firm	Reason
2026-03-26	Spacelabs Healthcare, Inc.	Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
2026-02-27	Spacelabs Healthcare, Inc.	Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurem
2025-10-31	Philips North America Llc	Potential issue where the IntelliVue monitors did not alarm.
2025-10-31	Philips North America Llc	Potential issue where the IntelliVue monitors did not alarm.
2025-10-31	Philips North America Llc	Potential issue where the IntelliVue monitors did not alarm.
2025-10-31	Philips North America Llc	Potential issue where the IntelliVue monitors did not alarm.
2025-10-31	Philips North America Llc	Potential issue where the IntelliVue monitors did not alarm.
2025-10-31	Philips North America Llc	Potential issue where the IntelliVue monitors did not alarm.
2025-10-31	Philips North America Llc	Potential issue where the IntelliVue monitors did not alarm.
2025-10-31	Philips North America Llc	Potential issue where the IntelliVue monitors did not alarm.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.