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Ingenia Elition S, Ingenia Elition X

FDA Recall #Z-0694-2019 — Class II — December 3, 2018

Recall #Z-0694-2019 Date: December 3, 2018 Classification: Class II Status: Terminated

Product Description

Ingenia Elition S, Ingenia Elition X

Reason for Recall

During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.

Recalling Firm

Philips Medical Systems Nederlands — Best

Classification

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

Product Type

Devices

Product Quantity

35

Distribution

CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.

Code Information

Software version R5.5.0 Serial numbers: 45027 45011 45010 45024 45032 45026 45054 45035 45051 45052 45007 45043 45044 45031 45039 45025 46001 45033 45050 45034 45049 45037 45048 46004 45046 45008 45058 45028 45029 45030 45042 46005 46011 45040 45045

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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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