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Patient Cable

GLOBAL INSTRUMENTATION, LLC · Model 001-400-0095 · UDI-DI 90815187020122

MLO Prescription
1
510(k) clearances
23
Adverse events (2 deaths)
2
Recalls
31
Facilities

Description

5 Lead Patient Cable, IEC, HR300

Recalls

DateFirmReason
2024-10-11Baxter Healthcare CorporationThere 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
2024-10-11Baxter Healthcare CorporationThere 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.