Recall Z-0905-2017 ยท IZI System, X-Ray, Angiographic
GE Healthcare, LLC
ADVANTX LCA
| Date | Nov 21, 2016 |
| Status | Terminated |
| Reason | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 11/21/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | Total for all products 1,598 (USA 824, OUS 774) |
| Distribution | US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong H |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945375 | ADVANTX LCA GE Medical Systems, Jan 30, 1995 |