Simpleware ScanIP 2016.09Recalls & 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 (K142779); 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. Jun 4, 2021Terminated

   A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data

   Z-2253-2021 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142779. One submission often covers many models, so check the product and lot details in each record.

• Z-2254-2021 · Jun 4, 2021 · Terminated
  Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.