Recall Z-0486-2012 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Healthcare AW Server version 2.0 with release 2.0 - 4.0 A medical software system that allows multiple users to remotely access AW applications from compatible computers on a network.
| Date | Jan 11, 2012 (initiated Nov 17, 2011) |
| Status | Terminated |
| Reason | 2 Unrelated Software Issues: An incorrect patient name maybe displayed when switching between two Volume Viewer tabs with different patients. Also, if a second patient exam is selected while the application is starting, the second patient's data will be displayed with the first patient's name display on the applications tab. |
| Root cause | Software design |
| Action | Consignees were sent on 11/17/11 a GE "Urgent Medical Device Correction" letters dated November, 16 2011 The letter was addressed to Hospital Administrators, Radiology Mangers and Risk Managers. The letter described the Safety Issue, Safety Instructions Affected Product Details, Product Correction and Contact Information. For the first issue, customers were asked to contact their field engineer to install the correct configuration file. Also, customers should not apply the recommended changes from the Customer Release Note as those changes cause the issue to occur. With the second issue, |
| Quantity | 308 |
| Distribution | Worldwide Distribution -- USA, including states of AZ, CA, CO, CT, DE, DC, FL, HI, IL, IN, LA, MD, MI, MN, MS,MO, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, and WI and countries of UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081985 | AW SERVER Ge Medical Systems, LLC, Sep 25, 2008 |