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.
Enforcement
- Recall Number
- Z-1752-2019
- Event ID
- 82668
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Healthcare, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 19, 2019
- Initiation Date
- March 29, 2019
- Classification Date
- June 10, 2019
- Termination Date
- April 15, 2021
- Address
- 3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States
Description
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.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
651789WDR1 and PL1005RX03
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.
825 (38 US and 787 OUS) in total