Device product
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.
Z-1752-2019
Product summary
- Event
- Event 82668
- Status
- Terminated
- Classification
- Class II
- Quantity
- 825 (38 US and 787 OUS) in total
- Official record key
device-enforcement:Z-1752-2019
Official wording
Reason: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Code information: 651789WDR1 and PL1005RX03
Distribution pattern: Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.
Derived failure modes
-
Unknown
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.