Data Foundry

Medical device recalls 2026

ARTIS icono floor — Class II medical device recall Z-2643-2026

Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2026-07-08, distributed nationwide. Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum l

Recall numberZ-2643-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2026-05-20
Classified2026-07-01
Reported by FDA2026-07-08
DistributedNationwide (US)
Quantity30 units
UPC / GTIN / UDI-DI04056869149325
Serial numbers174044, 174055, 174056, 174058, 174059, 174061, 174063, 174065, 174067, 174073, 174076, 174078, 174081, 174083, 174085, 174087, 174091, 174096, 174099, 174101, 174121, 174122, 174125, 174126, 174128 and 5 more
Model numbers11327700

Product

ARTIS icono floor. Model Number: 11327700.

Reason for recall

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2643-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.