FDA recall Z-1175-2026

Siemens Medical Solutions USA, Inc · Class II · device

Product

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02

Reason for recall

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.

Distribution

Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.

Key facts

Status
Ongoing
Initiation date
2025-12-29
Report date
2026-02-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2026