GE Healthcare CT Operator Console Images May Rotate During Scans
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. Images can rotate up to 56 degrees, potentially requiring patient rescans.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall with no reported illnesses or injuries. The hazard is diagnostic imaging malfunction where CT images may be progressively rotated, affecting diagnostic accuracy and potentially requiring patient rescans. Since no injury has been reported and the hazard is diagnostic rather than immediately life-threatening, this qualifies as a risk-of-harm product without reported injury, scoring 3 per the rubric.
Plain-English summary
GE Healthcare has identified a potential issue affecting certain Discovery, Optima, and Revolution series CT systems and related operator console upgrades. These systems may produce progressively rotated images, particularly during helical, cine, and cardiac scan modes.
After the first image in an exam, subsequent images rotate by increasing amounts depending on gantry speed and scan duration. Images can rotate up to approximately 56 degrees. The rotation is uniform across the anatomy without distortion, and the z-axis positioning remains correct. However, the apparent positioning of anatomical structures may be altered.
The affected systems have worldwide distribution. If technicians detect image rotation and repeat the exam, the same rotation pattern will recur. Small degrees of rotation might not be immediately visible. Affected healthcare facilities should contact GE Healthcare for device updates or service guidance.
The recalled product
- Product
- GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Hazard
- image-rotation
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI 00195278466488
- Serial/Sales Order Numbers: 5469298
- 5471981
- 5461542
- 5469371 4616154
Distribution
Distribution scope not specified by the agency.
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