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ARTIS icono biplane
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MEDICAL DEVICE RECALLMODERATE

ARTIS icono biplane

Siemens recalls ARTIS icono biplane over potential loss of movement after detector lift height adjustment.

What to do

Contact Siemens Medical Solutions USA, Inc. immediately to schedule a service update. Do not adjust the detector lift height to its maximum or minimum limits until the correction is applied.

Recalled
Listed
Updated
Recall No.
Z-2641-2026
Agency
FDA
Firm
Siemens Medical Solutions USA, Inc
Recall ID
99079
Status
ONGOING

Why it was recalled

Siemens Medical Solutions USA, Inc. is recalling the ARTIS icono biplane imaging system due to a potential loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. This issue could affect system positioning and may impact clinical procedures.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductModel
ARTIS icono biplane.11327600
ARTIS icono ceiling.11328100
ARTIS icono floor.11327700

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification