GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 00195278520852, Serial/Sales Order Numbers: CBFSG2400030HM, CBFSG2400032HM, CBFSG2400037HM, CBFSG2400034HM, CBFSG2400031HM, CBFSG2400035HM, CBFSG2400029HM, CBFSG2400028HM, CBFSG2400033HM, CBFSG2400036HM
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Healthcare (China) Co., Ltd.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
Product Codes/Lot Numbers:
UDI/DI 00195278520852, Serial/Sales Order Numbers: CBFSG2400030HM, CBFSG2400032HM, CBFSG2400037HM, CBFSG2400034HM, CBFSG2400031HM, CBFSG2400035HM, CBFSG2400029HM, CBFSG2400028HM, CBFSG2400033HM, CBFSG2400036HM
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0612-2025
Related Recalls
Brivo MR355, NMRI system
GE Healthcare (China) Co.
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
SIGNA Creator, SIGNA Explorer, NMRI systems
GE Healthcare (China) Co.
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
SIGNA MR355, SIGNA MR360, NMRI system
GE Healthcare (China) Co.
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.