Zenition 50 Medical Imaging Devices Wireless Foot Switch Recall
Philips is recalling Zenition 50 medical imaging devices because the wireless foot switch pedal may get stuck in the active position, causing unintended radiation emission.
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: FDA classified this as Class II. The hazard involves unintended radiation exposure, a significant risk of harm. The source does not report any actual illnesses or injuries, making this a theoretical risk scenario that meets the High severity threshold per the rubric.
Plain-English summary
Philips North America LLC is recalling the Zenition 50 medical imaging device (Product Code 718096) used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures. The recall affects all patients except neonates (birth to one month).
The wireless foot switch pedal may become stuck in the active position when the user releases it, resulting in unintended radiation emission. This defect creates a potential risk of patient exposure to unintended radiation during medical procedures.
Affected products include wireless foot switch sets and components with specific serial codes and UDI numbers as listed in the recall. The devices are distributed in the US. Healthcare facilities using these devices should contact Philips North America LLC or the FDA for information about remedy options.
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
- radiation-exposure
- stuck-pedal
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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