ARTIS icono ceiling. Model Number: 11328100.
FDA Recall Z-2642-2026 · Posted 2026-07-01
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-05-20
Product Quantity119 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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