FDAClass IIFebruary 23, 2022

Zenition 70 recall

Zenition 70, Model #718133

Why was Zenition 70 recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Zenition 70, Model #718133
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity
95 US; 284 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.
Recall date
February 23, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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