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ARTIS icono biplane. Model Number: 11327600 recallZ-2641-2026 · Siemens Medical Solutions USA, Inc · initiated May 20, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

Siemens notified consignees on about 05/19/2026 via letter. Consignees were instructed to ensure all users of the affected products within each organization and others who may need to be informed will receive the relevant safety information provided within the notice and comply with the recommendations therein, maintain the recall notification with product related records and until the corrective measures have been completed. Siemens will be releasing a software update to correct the issue via an Update Instruction AX018/26/S. All affected systems will be corrected by Siemens Healthineers. The service organization will contact consignees in the near future to arrange a date to perform the corrective action. Additionally, consignees were instructed to confirm and acknowledge receipt of the recall notification digitally.

Recall details

Recall number
Z-2641-2026
Status
Open, Classified
Initiated by the company
May 20, 2026
Posted by the FDA
Jul 1, 2026
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
85 units
Product code
OWB
FDA submissions
K241572
Distribution
US Nationwide distribution.

Product description

ARTIS icono biplane. Model Number: 11327600.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246, 184241, 184086, 184178, 184108, 184099, 184070, 184127, 184095, 184167, 184184, 184205, 184199, 184221, 184126, 184047, 184093, 184044, 184096, 184214, 184100, 184119, 184073, 184188, 184134, 184150, 184081, 184153, 184085, 184243, 184117, 184045, 184159, 184151, 184177, 184079, 184087, 184169, 184116, 184157, 184163, 184123, 184090, 184118, 184140, 184230, 184224, 184195, 184248, 184225, 184190, 184106, 184046, 184078, 184200, 184142, 184138, 184166, 184152, 184113, 184186, 184196, 184105, 184102, 184147, 184120, 184121, 184124, 184211, 184233, 184216, 184050, 184067, 184112, 184122, 184220, 184089, 184097, 184234, 184103, 184098, 184084, 184183, 184179, 184109

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K241572 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99079).

Sources and updates

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