Recalls / —

—#197596

Product

AXIOM Luminos Agile

FDA product code

JAA — System, X-Ray, Fluoroscopic, Image-Intensified

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K111292

Affected lot / code info

All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Worldwide distribution

Timeline

Recall initiated

2022-12-09

Posted by FDA

2023-01-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.