Optima CT680 ExpertRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K192686); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 5, 2024Open, Classified

   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.

   Z-0602-2025 · Root cause: Component design/selection · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192686. One submission often covers many models, so check the product and lot details in each record.

• Z-0606-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
• Z-0603-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
• Z-0610-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
• Z-0611-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
• Z-0612-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system