GE Healthcare CT Systems May Display Rotated Images in Diagnostic Scans
Certain GE Healthcare CT systems may produce progressively rotated images during diagnostic scans. If undetected and a rescan is needed, the same rotation recurs.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Class II medical device recall involves a diagnostic imaging defect that could affect radiological interpretation. No patient injuries or illnesses have been reported, but the image rotation poses a risk of diagnostic error if clinicians do not notice the issue.
Plain-English summary
GE Healthcare has identified a defect affecting 11 units of the Discovery RT CT system (Model 2374681-17) distributed worldwide. The systems may produce images that are progressively rotated during helical, cine, and cardiac scan modes. Starting with the first image of an examination, each subsequent image rotates by an increasing amount, with a maximum rotation of approximately 56 degrees.
The rotated images affect the entire anatomy by equal degrees without distortion. While anatomical positioning and the z-axis of images remain correct, the rotation can impair a radiologist's ability to accurately interpret the images. Small degrees of rotation might not be noticed, but if detected and a rescan is performed, the same rotation issue will occur with the replacement images.
Affected units are identified by UDI/DI 00840682118699 and specific serial numbers. Healthcare facilities with these systems should verify their equipment model and serial number against the recall list. Affected organizations should contact GE Healthcare for further guidance on managing this issue and any necessary service or software updates.
The recalled product
- Product
- GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 11
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 (12)
- UDI/DI 00840682118699
- Serial/Sales Order Numbers: CBDYG2400058HM
- CBDYG2400057HM
- CBDYG2400056HM
- CBDYG2400051HM
- CBDYG2400052HM
- CBDYG2400040HM
- CBDYG2400053HM
- CBDYG2400060HM
- CBDYG2400054HM
- CBDYG2400055HM
- CBDYG2400059HM
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by GE Healthcare (China) Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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