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HScribe HSCRIBE-6AC-XXXXBRecalls & reported problems

Mortara Instrument, Inc. · Holter Analysis System · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K004017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Oct 11, 2024Open, Classified

    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 (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

    Z-0320-2025 · Root cause: Software design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K004017. One submission often covers many models, so check the product and lot details in each record.

  • Z-0323-2025 · Oct 11, 2024 · Open, Classified
    Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

Other Electrocardiograph, Ambulatory, With Analysis Algorithm devices

All Electrocardiograph, Ambulatory, With Analysis Algorithm devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.