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ARGUS® PB-1000

Schiller AG · Model 3.920948 · UDI-DI 07613365000085

MHX Prescription

510(k) clearances

32,636

Adverse events (1,917 deaths)

285

Recalls

118

Facilities

Description

The ARGUS® PB-1000 parameter box is acquiring and monitoring patients vital parameters such as ECG, invasive blood pressure (IBP), temperature, non-invasive blood pressure (NIPB), CO2, SpO2 and Cardiac Output. All vital parameters and evaluations are registered and calculated in the ARGUS® PB-1000. This data is then transmitted to the visualization unit via a serial interface.

Recalls

Date	Firm	Reason
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.
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

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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.