Zenition 70 Radiological Device Wireless Foot Switch Unintended Radiation Recall
Philips Zenition 70 radiological imaging devices are recalled because their wireless foot switch pedal may become stuck in the active position when released, resulting in unintended radiation emission during diagnostic and surgical 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: FDA Class II device with risk of unintended radiation emission due to stuck foot switch pedal. No injuries or hospitalizations reported in source material. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity threshold.
Plain-English summary
Philips is recalling the Zenition 70 radiological imaging device (Product Code 718133) due to a malfunction of the wireless foot switch. The foot switch pedal may become stuck in the active position when released, resulting in unintended radiation emission during diagnostic, interventional, and surgical procedures.
The device is used for radiological guidance and visualization on patients except neonates (birth to one month old) and is distributed throughout the United States. When the wireless foot switch becomes stuck, unintended radiation may be emitted, potentially exposing patients and clinical staff to unexpected radiation during medical procedures.
The recall affects the Zenition 70 with Product Code 718133 and associated wireless foot switch sets and base stations identified by the product codes listed in the recall notice.
The recalled product
- Product
- Zenition 70. Product Code 718133. 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
- pedal-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)00884838091528(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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