PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 19, 2019 Initiated: March 29, 2019 #Z-1752-2019

Product 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.

Reason for Recall

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
825 (38 US and 787 OUS) in total
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
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.. Recalled by GE Healthcare, LLC. Units affected: 825 (38 US and 787 OUS) in total.
Why was this product recalled?
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 19, 2019. Severity: Moderate. Recall number: Z-1752-2019.