DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system.
FDA Recall Z-2008-2008 · Posted 2008-09-05
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeKPS
Date Initiated2008-03-10
Date Terminated2011-12-10
Product Quantity127
Reason for Recall
GE Healthcare has recently became aware of a cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient safety.
Firm Action
Field Modification Instructions (FMI No: 40815) will be issued to the field for the DST-XL product to install an arm or gantry rotation motor's brake. The customers letters "Product Safety Notification" dated March 10, 2008, have been distributed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter informs the customers of the safety issue, affected product, safety instructions, product correction and contact information.
If you have questions, please contact GE Healthcare within the US or Canada at 1-800-437-1171 or outside the US the telephone number at 1-262-896-2890.
Root Cause
Device Design
Distribution Pattern
AL, AR, CA , CO, DE , FL, IA, IL, KS, MA, MI, MS, NC , NJ, NY, OH, OK, PA , SC, TN, TX , VA, VT, WA United Kingdom, Belgium, Switzerland, Russia Federal Sweden, France, Italy, Spain, Germany Federal, Norway, Portugal, Netherlands, Saudi Arabia, Iran, India, Canada, Argentina, Taiwan, China, Bangladesh, Austria.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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