Z-0668-2010
Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and 5232083-4. For head, whole body...
GE Healthcare / initiated 2009-10-01 / Terminated
Ge Healthcare began a recall of 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... on . The reason FDA records is "Failure to properly document the CTDI in the Technical Reference or User Manual". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0668-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- GE Healthcare
- Product
- 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.
- Product code
- JAK System, X-Ray, Tomography, Computed
- Reason for recall
- Failure to properly document the CTDI in the Technical Reference or User Manual.
- FDA root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity in commerce
- 111 units total
- 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.
- Product codes and lots
- Serial numbers for the mentioned model numbers manufactured from November 2008 to November 2009.
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