RegWardenFDA facility compliance records
Recall

Class II — GE Healthcare, LLC

Recalling firmGE HealthCare Technologies Inc.
Registered facilityView this company's 50 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThere has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
ProductProteus 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.
Quantity825 (38 US and 787 OUS) in total
DistributionWorldwide 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,…
Initiated2019-03-29
Classified2019-06-10
Terminated2021-04-15
Recall numberZ-1752-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — GE Healthcare, LLC (Z-1752-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82668/

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