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Use caution Medical device recall · FDA · Published December 2, 2021

Philips Zenition 50 Wireless Foot Switch Recall: Firmware Issue May Cause Procedure Delays

Philips recalls Zenition 50 surgical systems with wireless foot switch model #718096 due to firmware issues that may cause procedure delays if the hand or wired switches aren't used.

🇺🇸 FDA recall #Z-0647-2022Medical devicePhilips ›
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Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 4-6 · Best, Netherlands
✎ GovInfoNow plain-language explainer

Philips is recalling Zenition 50 surgical systems with wireless foot switch model #718096 because a firmware issue can cause the wireless switch to stop working suddenly. This might delay or interrupt surgery if the hand switch isn't used or the wired switch isn't connected. Read more at govinfonow.com/recall/61475-philips-zenition-50-wireless-foot-switch-recall-firmware-issue-may.

Source Summary by GovInfoNow · govinfonow.com/recall/61475-philips-zenition-50-wireless-foot-switch-recall-firmware-issue-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0647-2022

Cite this page

“Philips Zenition 50 Wireless Foot Switch Recall: Firmware Issue May Cause Procedure Delays.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61475-philips-zenition-50-wireless-foot-switch-recall-firmware-issue-may. Based on FDA recall #Z-0647-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0647-2022%22&limit=1).

The FDA announced on Dec. 2, 2021, that Philips Medical Systems Nederland B.V. recalled the Zenition 50 monitor due to a firmware issue causing the wireless foot switch to stop responding. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Philips
  • Product: Zenition 50
  • Model #: 718096
  • Wireless Foot switch 3P : 459801238191
  • Wireless Foot switch 3P: 459801238231

The hazard

The wireless foot switch can suddenly stop responding due to a firmware issue. This failure could cause 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.

Context

GovInfoNow's records show Philips Medical Systems Nederland B.V. has 58 other recalls on record since May 26, 2021. Recent similar recalls include a Philips Telemetry Monitor 5500 recall dated June 5, 2026, and a Philips Smart-hopping 2.0 AP 1.4 GHz Patient Monitor recall dated Dec. 12, 2025.

How to tell if you have this one

Check for the wireless foot switch model numbers 459801238191 or 459801238231 on your Zenition 50 system. The product was sold with the model #718096.

  • Brand
    Philips
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • 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 numberProduct, codes & lotsQuantity
Z-0647-2022Zenition 50, Model #718096; Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 45980123823116 US; 76 ROW
Z-0648-2022Zenition 70, Model #718133; Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 45980123823195 US; 284 ROW
Z-0649-2022Veradius Unity, Model #718132; Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 45980123823112 US; 44 ROW
Based on the official FDA remedy

What to do — step by step

  1. Check Wireless Switch Function

    Verify if the wireless foot switch works properly by testing it during a procedure or by checking for sudden disconnections.

Where it went and when

Where it was distributed

Distributed in 26 states, and outside the U.S.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: yesMSAlabama: not listedALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Dec 2, 202112. FDA classified it Class II: Feb 17, 202223. Published in FDA’s Enforcement Report: Feb 23, 2022320212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0647-2022 (December 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0647-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA