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Optima CT660 Cj2.5 UpgradeRecalls & reported problems

GE Healthcare Japan Corporation · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

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.

8 other recalls cover devices cleared under the same FDA submission (K131576); 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 K131576. One submission often covers many models, so check the product and lot details in each record.

  • Z-0608-2025 · Nov 5, 2024 · Open, Classified
    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
  • Z-1900-2021 · Jun 14, 2021 · Open, Classified
    Revolution EVO, Optima CT660, Optima CT680 CT Systems.
  • Z-2584-2018 · May 24, 2018 · Terminated
    Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
  • Z-2583-2018 · May 24, 2018 · Terminated
    CT Goldseal Optima CT 600
  • Z-2870-2018 · Apr 27, 2018 · Terminated
    GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
  • Z-2873-2018 · Apr 27, 2018 · Terminated
    GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the follow
  • Z-2181-2017 · May 19, 2017 · Terminated
    GE Healthcare Revolution EVO X-ray system
  • Z-2182-2017 · May 19, 2017 · Terminated
    GE Healthcare Optima CT660, CT680 X-ray system

Other System, x-ray, tomography, computed devices

All System, x-ray, tomography, computed devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.