Philips Zenition 50 Wireless Foot Switch May Get Stuck, Emit Unintended Radiation
Philips is recalling Zenition 50 radiological devices because the wireless foot switch pedal may get stuck in active position, potentially causing unintended radiation emission during medical procedures.
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 FDA Class II recall involves potential unintended radiation exposure during medical procedures. The hazard is serious, but the source contains no reports of injuries or hospitalizations, qualifying this as a risk-of-harm product without reported injury.
Plain-English summary
Philips North America is recalling Zenition 50 radiological guidance and visualization devices (Product Code 718096). These devices are used during diagnostic, interventional, and surgical procedures on patients except neonates (birth to one month).
A wireless foot switch pedal in the recalled devices may become stuck in the active position when the user releases the pedal. If the pedal becomes stuck, it can result in the emission of unintended radiation during medical procedures.
The recalled devices were distributed in the United States.
The recalled product
- Product
- Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
- Manufacturer
- Philips North America Llc
- Hazard
- unintended-radiation
- equipment-malfunction
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 (8)
- Product UDI: (01)00884838091535(21). 459801442981
- Wireless foot switch set 3P (WFSS 3P) 459801238231
- Wireless foot switch 3P
- 459801257861
- WFS Base Station 459800627394
- Wireless foot switch set 3P 459800415535
- 459800415542
- WFS Base Station
Distribution
Distribution scope not specified by the agency.
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