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Revolution recallZ-0607-2025 · GE Healthcare (China) Co., Ltd. · initiated Nov 5, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare (China) Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a rescan is necessary or if the images need to be corrected during post-processing to ensure accurate interpretation and planning. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." A GE HealthCare representative will contact the consignee to arrange for the correction. For questions or concerns: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recall details

Recall number
Z-0607-2025
Status
Open, Classified
Initiated by the company
Nov 5, 2024
Posted by the FDA
Dec 4, 2024
Recalling firm
GE Healthcare (China) Co., Ltd.
Quantity
4 units
Product code
JAK
Distribution
Worldwide distribution.

Product description

GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system

Code information (models, lots, serial numbers)

UDI/DI 00195278385215, Serial/Sales Order Numbers: CBDPG2400006HM, CBDPG2400005HM, CBDPG2400004HM, CBDPG2400007HM

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95704).

Sources and updates

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