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Open, Classified

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

FDA Recall Z-1311-2023 · Posted 2023-03-30

Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2023-02-02
Product Quantity141 units US

Reason for Recall

In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

Firm Action

Siemens Healthcare issued A Customer Safety Advisory Notice distributed to customers on 2/2/23 via AX041/22/S. A software update to correct the error will be distributed to all affected customers via Update Instructions AX040/22/S. Affected systems will be updated to SW version VE10B. Letter states reason for recall, health risk and action to take: Please perform system movements with adequate care to avoid injuries to persons and damage to equipment due to collisions or crushing. Siemens will correct the software error via Update Instructions AX040/22/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content.

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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