Recall Z-1973-2015 ยท IZI System, X-Ray, Angiographic
GE Healthcare
GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
| Date | Jul 3, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). |
| Root cause | Nonconforming Material/Component |
| Action | The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of |
| Quantity | 3 |
| Distribution | Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and |
| 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 |