Recall Z-0763-2016 ยท OWB Interventional Fluoroscopic X-Ray System
GE Medical Systems, LLC
Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ
| Date | Dec 18, 2015 |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 12/18/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12239 dated December 18, 2015. The letter was address to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 2,111 (1078 US; 1033 OUS) |
| Distribution | Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and the countries of Algeria, Angola, Argentina, Australia, Bahrain, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022322 | INNOVA AND INNOVA 2000 S Ge Medical Systems, Inc., Oct 8, 2002 |
| K042053 | INNOVA 4100, INNOVA 3100 Ge Medical Systems, Inc., Aug 26, 2004 |
| K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE Healthcare, Jan 2, 2013 |
| K945375 | ADVANTX LCA GE Medical Systems, Jan 30, 1995 |
| K960575 | ADVANTX LCV+ GE Medical Systems, May 7, 1996 |
| K974367 | ADVANTX LCN, ADVANTX LCLP GE Medical Systems, Feb 13, 1998 |