LUMINOS Q.namix R 11574002Recalls & 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 (K250660); 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. Dec 29, 2025Class IIOpen, Classified

   Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

   Z-1174-2026 · Root cause: Software design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K250660. One submission often covers many models, so check the product and lot details in each record.

• Z-1175-2026 · Dec 29, 2025 · Open, Classified
  Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02