Official recall record

GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems

What the authority reported

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

More recalls: US FDA — Medical Devices · China · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

• 2024-11-05 · US FDA — Medical Devices
  GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system

Other recalls from this brand

• 2025-01-31 · US FDA — Medical Devices
  Brivo MR355, NMRI system
• 2025-01-31 · US FDA — Medical Devices
  SIGNA MR355, SIGNA MR360, NMRI system
• 2025-01-31 · US FDA — Medical Devices
  SIGNA Creator, SIGNA Explorer, NMRI systems