Recall StatusTerminated
Date Initiated2011-11-17
Date Terminated2012-07-03
Product Quantity308
Reason for Recall
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.
Firm 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, customers are to wait until the application has fully initialized before making another patient exam selection. GE Healthcare will correct all affected AW server installations via a software upgrade at no cost to the customer. A representative will contact customers to arrange for the correction. Questions should be directed to customers' local GE Healthcare Service Representative or at the numbers provided in the letter.
Root Cause
Software design
Distribution Pattern
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, REUNION, QATAR, POLAND, NORWAY, NEW ZEALAND, LEBANON, SOUTH KOREA, JAPAN, ITALY, ISRAEL, HONG KONG, GUADELOUPE, GREAT BRITAIN, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CANADA, BRAZIL, BOSNIA AND HERZEGOVINA, BELGIUM, and AUSTRALIA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.