PlainRecordsFDA · Medical device recall
Discovery CT 750 HD model numbers: 5232083… and 1 more product
- Date posted by the FDA
- Feb. 2, 2010
- Status
- Terminated
- Filed by
- Ge Healthcare
- Reason
- Failure to properly document the CTDI in the Technical Reference or User Manual.
- 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.
2 products in this recall
Discovery CT 750 HD model numbers: 5232083…
- 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.
- Quantity
- 111 units total
- Codes and lots
- Serial numbers for the mentioned model numbers manufactured from November 2008 to November 2009.
- Recall started
- Oct. 1, 2009
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0668-2010
LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909…
- 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.
- Quantity
- 111 units total
- Codes and lots
- Serial numbers associated with the mentioned Gantry model numbers manufactured from May 2009 to November 2009.
- Recall started
- Oct. 1, 2009
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0669-2010
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0668-2010, Z-0669-2010. The agency record governs; check it and the company before acting.