3mensio Workstation 10.6Recalls & 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 still open.

1 other recall cover devices cleared under the same FDA submission (K153736, K250330); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 14, 2025Class IIOpen, Classified

   When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage

   Z-2297-2025 · Root cause: Software change control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153736, K250330. One submission often covers many models, so check the product and lot details in each record.

• Z-2767-2026 · May 7, 2026 · Open, Classified
  3mensio Workstation (Vascular Fenestrated) software