Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile…
Philips Medical Systems Nederland B.V. · Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Open FDA's page for this record- Cfres ID
- 213230
- Product res number
- Z-1583-2025
- Event date initiated
- 2023-07-20
- Event date posted
- 2025-04-21
- Recall status
- Open, Classified
- Res event number
- 96598
- Product code
- OWB
- Code info
- Zenition 70
- Firm FEI number
- 3000976525
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Address 1
- High Tech Campus 36 36 high tech campus
- City
- Eindhoven
- Country
- Netherlands
- Additional info contact
- Dusty Leppert, CHP 978-228-0190
- Reason for recall
- Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
- Root cause description
- Software design
- Product quantity
- 12 systems
- Distribution pattern
- US Nationwide distribution
- Product description
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
- Action
Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the following actions that should be taken to prevent risks to patients: Keep the Electronic Product Radiation Correction letter with the documentation of the system. Where possible, place the Wireless Foot Switch within a 3 meter range from the C-arm stand to minimize as much as possible the potential delay of 72 milliseconds. Circulate this Electronic Product Radiation Correction letter to all users of the system so that they are aware of the issue. Philips will contact customers to schedule a visit to arrange for a Field Service Engineer visit to update the Software free of charge. (Philips reference 2024-IGT-PUN-007).
- K numbers
- K183040, K212813
- 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