Recall Z-2008-2008 ยท KPS System, Tomography, Computed, Emission
GE Healthcare
DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system.
| Date | Sep 5, 2008 (initiated Mar 10, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 tele |
| Quantity | 127 |
| Distribution | 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, Taiw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942837 | DST-XL Sopha Medical Systems, Inc., Jan 5, 1995 |