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Luminos Agile Max (VE10, VF10, VF11)

FDA Recall #Z-1479-2023 — Class II — November 23, 2022

Recall #Z-1479-2023 Date: November 23, 2022 Classification: Class II Status: Ongoing

Product Description

Luminos Agile Max (VE10, VF10, VF11)

Reason for Recall

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.

Recalling Firm

Siemens Medical Solutions USA, Inc — Malvern, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

704 units in the United States (1945 units worldwide)

Distribution

US Nationwide - Worldwide Distribution

Code Information

Model: 10762472

Status

Ongoing

Voluntary / Mandated

FDA Mandated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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