Recall Z-1245-2014 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac)
| Date | Mar 20, 2014 (initiated Feb 14, 2014) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO) |
| Root cause | Software design |
| Action | The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 14, 2014 to its Consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Directors and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and recommended actions. A GE Healthcare Service representative will perform the required software update on each affe |
| Quantity | 33 (21 US, 12 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) to states of: CO, IN, MA, NJ, NC, OH, PA, TX, and VA; and countries of: Algeria,France, Germany, Poland, Russia, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093581 | DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS Ge Medical Systems, LLC, Apr 19, 2011 |