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Open, Classified

ARTIS icono biplane. Model Number: 11327600.

FDA Recall Z-2641-2026 · Posted 2026-07-01

Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-05-20
Product Quantity85 units

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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