Home / Recalls / GE Healthcare, LLC / Z-1900-2021

Z-1900-2021 Class II Ongoing

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
July 7, 2021
Initiation Date
June 14, 2021
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
3665

Product Description

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Reason for Recall

Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

Distribution Pattern

3,665 (US = 956; OUS = 2,709)

Code Information

Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2

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  • Z-1483-2025 Class II — GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; (February 19, 2025)
  • Z-1486-2025 Class II — GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203390 (February 19, 2025)
  • Z-1485-2025 Class II — GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-0 (February 19, 2025)
  • Z-1484-2025 Class II — GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; (February 19, 2025)
  • Z-1487-2025 Class II — GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers (February 19, 2025)
  • Z-0318-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2 (October 3, 2024)
  • Z-0039-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/C (August 29, 2024)