GE Healthcare AW Server version 2.0 with release 2.0…

Date posted by the FDA

Jan. 11, 2012

Status

Terminated

Filed by

GE Healthcare, LLC

Product

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.

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.

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.

Quantity

308

Codes and lots

Serial Number 00000196120GE0 00000211977GE4 00000211976GE6 00000211975GE8 00000213559GE8 00000213558GE0 00000209172GE6 00000211978GE2 00000214205GE7 00000214206GE5 00000214821GE1 00000216331GE9 00000217429GE0 00000217427GE4 00000217428GE2 00000217426GE6 00000218090GE9 00000216334GE3 00000214817GE9 00000219372GE0 00000218207GE9 00000214818GE7 00000218205GE3 00000216335GE0 00000222534GE0 00000219371GE2 00000222536GE5 00000222533GE2 00000223236GE1 00000223240GE3 00000223235GE3 00000223242GE9 00000223234GE6 00000223243GE7 00000222535GE7 00000216337GE6 00000223238GE7 00000216340GE0 00000216336GE8 00000216338GE4 00000183554HP5 00000183573HP5 00000183555HP2 00000183518HP0 00000183570HP1 00000183568HP5 00000183562HP8 00000183557HP8 00000183561HP0 00000183558HP6 00000183567HP7 00000183563HP6 00000183565HP1 000001010056GS 000001010012GS 00000229342GE1 00000229343GE9 00000229341GE3 00000229339GE7 00000235883GE6 00000235884GE4 00000235885GE1 00000235886GE9 00000240703GE9 00000240704GE7 00000240705GE4 00000240706GE2 00000240707GE0 00000240708GE8 00000246497GE2 00000246498GE0 00000248243GE8 00000248244GE6 00000246500GE3 00000253048GE3 000001010023GS 0000AD11104005 0000AD11104004 00000P10347010 00000Y11013009 0000AB11054003 00000A11096009 00000P10347005 0000AD11087005 000001010019GS 000001010045GS 00000P11244008 00000Z10335002 00000Y11013001 000001010024GS 000001010040GS 00000F11206003 00000V11136003 00000P10312010 000001010041GS 00000A11096003 0000AA11157004 00000L11074006 00000P10312008 00000P10347003 00000V11185002 00000L11074004 00000J11056005 00000P10347007 0000AB11054004 0000AB11054002 0000AB11054005 00000L11074009 00000L11074002 00000L11074007 00000L11074003 0000AD11087001 0000AD11104003 0000AD11104002 0000AD11104001 00000A11096004 000001010004GS 000001010003GS 000001010005GS 00000A11096002 00000L11071009 0000AD11138002 0000AD11087003 00000183531HP3 000001010042GS 000001010044GS 000001010043GS 00000A11096006 0000AB10329002 00000Z10335010 00000Z10335006 000001010016GS 000001010018GS 000001010022GS 000001010017GS 000001010057GS 00000K11199001 00000C11263003 00000183514HP9 000001010059GS 00000P11244012 00000K11152002 00000P10312002 00000E11026009 00000E11026008 00000E11026002 00000Y11013003 00000P10347009 00000P10347011 00000J11056002 00000J11056001 00000J11056003 00000J11056004 000001010001GS 000001010002GS 000001010027GS 00000V11136005 00000F11206002 00000P11244013 00000P10312001 0000AB10329001 0000AB10329003 00000Z10335003 00000Z10335004 00000Z10335008 00000Y11013008 00000Y11013007 00000E11026005 000001010026GS 000001010013GS 0000AD11138005 0000AD11138003 00000K11230001 00000P11244001 00000P10312007 00000P10312005 00000Z10335005 00000Z10335007 00000Z10335001 00000P10347004 00000P10312003 00000G10363002 00000P10347008 00000G10363001 00000Y11013002 00000Y11013010 00000Y11013005 00000E11026007 00000E11026010 00000E11026003 00000P10312009 00000E11026001 00000E11026004 00000L11074005 0000AD11087004 00000183537HP0 00000183552HP9 00000183528HP9 00000183506HP5…

Recall started

Nov. 17, 2011

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-0486-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0486-2012. The agency record governs; check it and the company before acting.