Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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.