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PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System

MEDICALGORITHMICS S A · Model Type: PECGT-IIIV · UDI-DI 05903021560025

DSI Prescription
10
510(k) clearances
33,398
Adverse events (508 deaths)
82
Recalls
118
Facilities

Description

The PocketECG transmitter is a key component of the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-IIIV is inteded for use in CDMA cellular networks.

Recalls

DateFirmReason
2026-03-26Spacelabs Healthcare, Inc.Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
2026-02-27Spacelabs 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
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential 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.