FDA (Devices) recall action 89437
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
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 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.
Philips is recalling Zenition 70 wireless foot switches due to a firmware issue that can cause the device to stop responding. This could interrupt imaging procedures if alternative controls are not used.