DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed
FDA device recall Z-2008-2008 · posted 2008-09-05 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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,
- Date initiated
- 2008-03-10
- Date posted
- 2008-09-05
- Date terminated
- 2011-12-10
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DST-XL (K942837) | Sopha Medical Systems, Inc. | 1995-01-05 |