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Open, Classified

System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

FDA Recall Z-1040-2023 · Posted 2023-01-30

Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2022-12-16
Product Quantity609 US; 1627 worldwide

Reason for Recall

In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

Firm Action

On December 16, 2022, the firm initiated the recall to its affected customers via Urgent Medical Device Correction letters. Customers were instructed to do the following: Observe if the system suffers an abrupt shutdown. This can be caused e.g., by usage of the Emergency SHUTDOWN button, manually switching off via End session / Shutdown System command in the main menu, or by a long press on the power-on push button on the system console. In the event of an abrupt shutdown, restart immediately to verify system state and call service if necessary. The firm will provide a software patch to affected systems. Siemens's service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.

Root Cause

Software design

Distribution Pattern

Worldwide - 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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