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Midmark IQholter Digital Holter

MIDMARK CORPORATION · Model 4-000-0110 · UDI-DI 00841709100598

MLO Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

The Midmark IQholter system combines a compact digital recorder with three powerful software applications. Easy-to-use Holter software with fully automated analysis and reporting, designed for routine monitoring situations in fast-paced offices. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key USB Version, and Holter Prep Kits.

Recalls

Date	Firm	Reason
2024-10-11	Baxter Healthcare Corporation	There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System
2024-10-11	Baxter Healthcare Corporation	There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System

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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.