The Recall Desk
ModerateFDA (Devices)·Z-0647-2022·Announced 2022-02-23

Wireless Foot Switch May Stop Responding During Medical Procedures

Philips is recalling Zenition 50 wireless foot switches (Model #718096) because a firmware issue can cause them to suddenly stop responding, potentially delaying medical procedures.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a firmware-related operational failure rather than a direct safety threat, and alternative control methods are available.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Zenition 50 wireless foot switch, Model #718096. The device is used to control medical procedures and is distributed domestically across multiple U.S. states and internationally.

The wireless foot switch contains a firmware defect that can cause it to suddenly stop responding. If the foot switch fails and no alternative control method (such as a hand switch or wired foot switch) is immediately available or in use, the medical procedure may be delayed or interrupted.

Healthcare facilities should verify that the wireless foot switch is functioning properly and ensure that alternative control methods are available as a backup. Contact Philips Medical Systems Nederland B.V. for firmware updates or repair instructions.

The recalled product

Product
Zenition 50, Model #718096
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
  • firmware-issue
  • device-malfunction
  • procedure-delay

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed in 26 states:

  • 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