ImageDrive Clinical 1.1Recalls & reported problems

Summary

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

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K153284); 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. Feb 26, 2020Terminated

   A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

   Z-1758-2020 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153284. One submission often covers many models, so check the product and lot details in each record.

• Z-1759-2020 · Feb 26, 2020 · Terminated
  Synaptive ImageDrive Clinical