Recalls / —
—#87769
Product
LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry. For head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- FDA product code
- JAK — System, X-Ray, Tomography, Computed
- Device class
- Class 2
- Medical specialty
- Radiology
- Affected lot / code info
- Serial numbers associated with the mentioned Gantry model numbers manufactured from May 2009 to November 2009.
Why it was recalled
Failure to properly document the CTDI in the Technical Reference or User Manual.
Root cause (FDA determination)
Radiation Control for Health and Safety Act
Action the firm took
GE is sending an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect, identify the affected product details, provide instructions, state the product correction, and the necessary contact information.
Recalling firm
- Firm
- Ge Healthcare
- Address
- 9900 W Innovation Dr, Wauwatosa, Wisconsin 53226-4856
Distribution
- Distribution pattern
- Nationwide Distribution -- Including states of CT, SD, VA, WA, MA, PA, GA, IL, CA, MD, NY, NC, SC, AZ, TX, MT, FL, OH, OK, MI, CO, ME, WV, TN, KS, and WI.
Timeline
- Recall initiated
- 2009-10-01
- Posted by FDA
- 2010-02-02
- Terminated
- 2011-12-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #87769. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.