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GE Medical Systems, LLC recalls

The FDA has posted 76 enforcement recalls from GE Medical Systems, LLC since 2025, none of them Class I (most serious). Most recent report: Jun 24, 2026.

Class II: 76
Class IIOngoingZ-2475-2026

GE Medical Systems, LLC recalls Giraffe OmniBed

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device.…

  • Neonatal Incubator
  • Component design/selection
GE Medical Systems, LL…WIJun 24, 2026
Class IIOngoingZ-2151-2026

GE Medical Systems, LLC recalls Revolution Apex Elite

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Asce…

  • Computed Tomography X-Ray System
  • Software design
GE Medical Systems, LL…WIMay 20, 2026
Class IIOngoingZ-2149-2026

GE Medical Systems, LLC recalls Revolution Ascend

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Asce…

  • Computed Tomography X-Ray System
  • Software design
GE Medical Systems, LL…WIMay 20, 2026
Class IIOngoingZ-2155-2026

GE Medical Systems, LLC recalls Revolution Apex Select

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Asce…

  • Computed Tomography X-Ray System
  • Software design
GE Medical Systems, LL…WIMay 20, 2026
Class IIOngoingZ-2154-2026

GE Medical Systems, LLC recalls Revolution Apex

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Asce…

  • Computed Tomography X-Ray System
  • Software design
GE Medical Systems, LL…WIMay 20, 2026

Firm name as filed with the FDA: “GE Medical Systems, LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.