Summary
The FDA issued a Class II for Zenition 50, Model #718096 by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0647-2022
Action Date
2022-02-23
Status
Ongoing
Category
device
Product Description
Zenition 50, Model #718096
Lot/Code Info: Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231
Quantity Affected: 16 US; 76 ROW
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-02
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0647-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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