Zenition 70 Radiological System Wireless Foot Switch Recall
Philips is recalling Zenition 70 radiological systems with wireless foot switches that may stick in the active position when released, 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: FDA Class II recall involving a medical device with potential for patient radiation exposure due to malfunction; the source text does not report any illnesses or injuries, making this a risk-of-harm scenario without reported adverse events, consistent with a High severity rating.
Plain-English summary
Philips North America LLC is recalling Zenition 70 radiological systems used for guidance and visualization during diagnostic, interventional, and surgical procedures. The devices use wireless foot switch components (Product Code 718133 with multiple wireless foot switch set and base station configurations) that are subject to this recall.
A wireless foot switch pedal may become stuck in the active position when the user releases the pedal. This malfunction can result in the emission of unintended radiation during medical procedures.
The affected devices were distributed in the United States. Patients treated with affected systems may have been exposed to unintended radiation. Healthcare facilities should immediately discontinue use of affected wireless foot switch components and contact Philips for replacement or repair instructions.
This is a Class II recall issued by the U.S. Food and Drug Administration.
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
- 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)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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