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FUKUDA DENSHI
FUKUDA DENSHI CO.,LTD. · Model FCS-64G · UDI-DI 04538612913778
1
510(k) clearances
32,228
Adverse events (1,909 deaths)
283
Recalls
118
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-05 | Philips North America Llc | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI |
| 2026-06-04 | Spacelabs Healthcare, Inc. | Due to off-the-shelf display port component that has audio/video failures |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result |
| 2026-02-20 | Masimo Corporation | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati |
| 2026-02-20 | Masimo Corporation | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati |
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Get your free API keyRead the docsData 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.