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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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
Part of a larger recall action
This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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