Revolution EagleRecalls & 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 (K123596); 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. Jun 2, 2022Open, Classified

   As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

   Z-1511-2022 · Root cause: Error in labeling · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123596. One submission often covers many models, so check the product and lot details in each record.

• Z-0604-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
• Z-0601-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
• Z-2585-2018 · May 24, 2018 · Terminated
  Optima CT 520
• Z-2185-2017 · May 19, 2017 · Terminated
  GE Healthcare Optima CT520 X-ray system
• Z-0840-2014 · Oct 9, 2013 · Terminated
  GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data t