LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry. For he
FDA device recall Z-0669-2010 · posted 2010-02-02 · Terminated
Recall details
- Recalling firm
- Ge Healthcare
- Reason for recall
- Failure to properly document the CTDI in the Technical Reference or User Manual.
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2009-10-01
- Date posted
- 2010-02-02
- Date terminated
- 2011-12-10
- Location
- Wauwatosa, WI
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