Exact FDA event identifier

Event 98244

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 29, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

Z-1174-2026

Recall number: Z-1174-2026
Initiated: December 29, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Siemens Medical Solutions USA, Inc
Quantity: 41 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Siemens Material Number (SMN): 11574002; UDI-DI: 04056869993973; Serial Numbers: 150050, 150035, 150033, 150034, 150048, 150021, 150020, 150053, 150023, 150044, 150049, 150037, 150054, 150011, 150059, 150024, 150038, 150051, 150029, 150045, 150032, 150056, 150043, 150055, 150041, 150026, 150025, 150022, 150031, 150039, 150046, 150042, 150028, 150047, 150030, 150052, 150027, 150057, 150040, 150058, 150063;

Distribution pattern

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.

device · product 2 of 2

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

Z-1175-2026

Recall number: Z-1175-2026
Initiated: December 29, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Siemens Medical Solutions USA, Inc
Quantity: 7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Siemens Material Number (SMN): 11574003; UDI-DI: 04056869993980; Serial Numbers: 170013, 170022, 170023, 170021, 170020, 170025, 170026;