Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and 5232083-4. For head, whole body, cardiac and vascular X-ray Computed Tomography applications.
This recall has been terminated (originally issued February 2, 2010).
- Company
- Ge Healthcare
- Recall Initiated
- October 1, 2009
- Posted
- February 2, 2010
- Terminated
- December 10, 2011
- Recall Number
- Z-0668-2010
- Quantity
- 111 units total
- Firm Location
- Wauwatosa, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Failure to properly document the CTDI in the Technical Reference or User Manual.
Distribution
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.
Lot / Code Info
Serial numbers for the mentioned model numbers manufactured from November 2008 to November 2009.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.
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