Recall Z-0023-2014 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
| Date | Oct 17, 2013 (initiated Mar 26, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID |
| Root cause | Software design (manufacturing process) |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 26, 2013. The letter was addressed to Director of Radiology, Emergency Medicine Physicians and Radiologic Technologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. |
| Quantity | 380 (52 US & 328 OUS) |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPU |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110227 | OPTIMA CT660 Ge Medical Systems, LLC, Jul 20, 2011 |