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Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG
MEDICALGORITHMICS S A · Model Type: PC Client · UDI-DI 05903021560001
DSI
Prescription
10
510(k) clearances
33,398
Adverse events (508 deaths)
82
Recalls
119
Facilities
Description
The PC Client software is an accessory to the Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III and Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV. The PC Client application allows managing the recording sessions and reviewing the ECG data that was recorded by the patient monitors.
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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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.