NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Class I - DangerousWhat Should You Do?
- Check if you have this product: N64E120022E; N64E130039E; N641130051 E; N64E130062E; N64E130063E; N64E130066E;1 N641140077E; N64E140116E; N641140117E; N641140118E; N641140119E; N641140120E; N64EN150043E; N64E150121E; N64E150125E; N641150129E; N641150131 E; N641150136E; N641N160066E; N641N160067E; N64EN160068E; N64EN160071 E; N64EN160082E; N64EN160085E; N64EN160086E; N641N1 70093E; N641N1701 05E; N641N1 701 16E; N641N170120E; N641N170127E; N641N170128E; N641N170129E; N641N180156E; N641N180157E; N641N180161E; N641N180162E; N641N180205E
- 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:
- Neusoft Medical Systems Co., Ltd.
- Reason for Recall:
- Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Product Codes/Lot Numbers:
N64E120022E; N64E130039E; N641130051 E; N64E130062E; N64E130063E; N64E130066E;1 N641140077E; N64E140116E; N641140117E; N641140118E; N641140119E; N641140120E; N64EN150043E; N64E150121E; N64E150125E; N641150129E; N641150131 E; N641150136E; N641N160066E; N641N160067E; N64EN160068E; N64EN160071 E; N64EN160082E; N64EN160085E; N64EN160086E; N641N1 70093E; N641N1701 05E; N641N1 701 16E; N641N170120E; N641N170127E; N641N170128E; N641N170129E; N641N180156E; N641N180157E; N641N180161E; N641N180162E; N641N180205E
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1279-2019
Related Recalls
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
Software defect