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Open, Classified

AXIOM Luminos Agile

FDA Recall Z-1001-2023 · Posted 2023-01-20

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeJAA
Date Initiated2022-12-09
Product Quantity271 units

Reason for Recall

There is potential for the footrest to detach from the patient table during use.

Firm Action

A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructions for Use for each reported system.

Root Cause

Process control

Distribution Pattern

Worldwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111292LUMINOS AGILESiemens Medical Solutions USA, Inc. · 2011-06-03

Official Source

View FDA Recall →

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

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