Recall Z-0413-2016 ยท IZI System, X-Ray, Angiographic
GE Medical Systems, LLC
GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluorosc
| Date | Nov 13, 2015 |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems . |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#12237 dated November 13, 2015 to customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 108 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Marti |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE Healthcare, Jan 2, 2013 |