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Zenition 50, Model #718096

FDA Recall #Z-0647-2022 — Class II — December 2, 2021

Recall #Z-0647-2022 Date: December 2, 2021 Classification: Class II Status: Ongoing

Product Description

Zenition 50, Model #718096

Reason for Recall

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Recalling Firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

Classification

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

Product Type

Devices

Product Quantity

16 US; 76 ROW

Distribution

Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.

Code Information

Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231

Status

Ongoing

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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