The Recall Desk
HighFDA (Devices)·Z-0649-2022·Announced 2022-02-23

Wireless Foot Switch Firmware Issue in Philips Veradius Unity Devices

The wireless foot switch in Philips Veradius Unity medical systems can lose function due to a firmware issue. This could cause delays or interruption of medical procedures if alternative input methods are not used.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall. The hazard is a firmware-induced loss of equipment function that could cause procedure delays or interruption, representing a risk of harm. However, no illnesses or injuries have been reported, limiting the score to 3 per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Philips Medical Systems is recalling the wireless foot switch (Model #718132) used with Veradius Unity medical systems. The manufacturer discovered that the wireless foot switch can suddenly stop responding due to a firmware issue.

Affected units include 12 systems distributed domestically across the United States and 44 units distributed internationally. If the wireless foot switch fails and is the only foot switch input method in use, this could cause delays or interruption of medical procedures.

Healthcare facilities using this equipment should verify that alternative input methods—such as the hand switch or wired foot switch—are available and functional on their systems. Users should contact Philips Medical Systems for guidance on firmware updates or replacement of the wireless foot switch.

The recalled product

Product
Veradius Unity, Model #718132
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Surgical Foot Switch
Hazard

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:

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.

See all 3 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · firmware issue

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