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Terminated

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.

FDA Recall Z-0668-2010 · Posted 2010-02-02

Recalling FirmGe Healthcare
Recall StatusTerminated
Product CodeJAK
Date Initiated2009-10-01
Date Terminated2011-12-10
Product Quantity111 units total

Reason for Recall

Failure to properly document the CTDI in the Technical Reference or User Manual.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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