Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and su…
Philips North America Llc · A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Open FDA's page for this record- Cfres ID
- 213227
- Product res number
- Z-1580-2025
- Event date initiated
- 2025-02-25
- Event date posted
- 2025-04-21
- Recall status
- Open, Classified
- Res event number
- 96593
- Product code
- OWB
- Firm FEI number
- 3016618143
- Recalling firm
- Philips North America Llc
- Address 1
- 222 Jacobs St
- City
- Cambridge
- State
- MA
- Postal code
- 02141-2289
- Reason for recall
- A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Root cause description
- Labeling design
- Distribution pattern
- US
- Product description
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.
- Code info
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, Wireless foot switch 3P, 459800415542, WFS Base Station
- Action
Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. Philips proposes sending the Electronic Product Radiation Defect notification to customers immediately upon FDA approval of the corrective action plan, and completion of the remaining activities within 4 months of FDA approval of the corrective action plan. This corrective action does not require any customer transportation reimbursement. The following statement is included in the customer communication: The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. Draft of letter provided. Philips commits to notifying the FDA on a monthly basis providing progress with this field correction.
- K numbers
- K183101
- Harmonized identifiers (openFDA)
- Device name
- Interventional Fluoroscopic X-Ray System
- Medical specialty description
- Radiology
- Regulation number
- 892.1650
- Device class
- 2
- K number
- K221230, K151598, K103416, K171565, K043076, K253584, K033486, K083545, K051064, K234067, K070123, K150967, K212383, K200360, K213768, K993037, K220311, K220409, K041931, K171755, K122457, K212557, K232344, K200074, K151904, K220342, K252503, K243735, K231701, K101868, K024200, K233107, K250241, K142740, K233230, K132970, K213479, K121772, K230949, K082243 +285 more
- Registration number
- 3033525987, 1720753, 3035950510, 3009963139, 1056553, 3002466018, 3030089787, 3021027284, 8043933, 3014328942, 1054713, 3005172103, 3011713200, 3018077344, 3006544299, 3010703925, 1835251, 3036255956, 3014343100, 3008284470, 3008496839, 3011347852, 2243057, 3010162973, 3010398867, 3014134519, 3005706667, 3004977335, 3003768277, 3003202425, 3049422862, 3011416394, 3004785967, 3012631246, 3043048939, 3018596740, 3016619943, 3003477135, 3012911444, 3021060474 +86 more
- FEI number
- 3033525987, 1720753, 3035950510, 3009963139, 3002466018, 3030089787, 3000209794, 3021027284, 3014328942, 3005172103, 3011713200, 3018077344, 3006544299, 3010703925, 3036255956, 3014343100, 3008284470, 1000208827, 3008496839, 3011347852, 2243057, 3010398867, 3014134519, 3005706667, 3004977335, 3003202425, 3002807880, 3049422862, 3011416394, 3004785967, 3012631246, 3002808139, 3043048939, 3018596740, 3016619943, 3000205591, 3003477135, 3002980729, 3012911444, 3021060474 +86 more