FDA Device Intelligence
HomeSchiller AG › ARGUS PB-3000

ARGUS PB-3000

Schiller AG · Model PB-3000 Var.8, sub-variant: Q · UDI-DI 07613365003468

MHX Prescription
1
510(k) clearances
32,228
Adverse events (1,909 deaths)
283
Recalls
118
Facilities

Description

The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data.

Recalls

DateFirmReason
2026-06-05Philips North America LlcPotential 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
2026-06-04Spacelabs Healthcare, Inc.Due to off-the-shelf display port component that has audio/video failures
2026-04-24GE Medical Systems Information Technologies IncGE 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
2026-04-24GE Medical Systems Information Technologies IncGE 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
2026-04-24GE Medical Systems Information Technologies IncGE 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
2026-04-24GE Medical Systems Information Technologies IncGE 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
2026-04-24GE Medical Systems Information Technologies IncGE 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
2026-04-24GE Medical Systems Information Technologies IncGE 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
2026-02-20Masimo CorporationTwo devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati
2026-02-20Masimo CorporationTwo devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.