Skip to content
Recall Observatory FDA recall evidence

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

March 29, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
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

    reason.no_named_rule · v1.0.0

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