Advantage Workstation version 4.2P…

Date posted by the FDA

Sept. 20, 2008

Status

Terminated

Filed by

GE Healthcare

Product

Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.

Reason

GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.

Distribution pattern

AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Algeria Argentina Australia Austria Belgium Bosnia Brazil Bulgaria Byelorussian SSR Canada Chile China Columbia Croatia Cyprus Czech Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Guadeloupe Guatemala Guyana Honduras Hungary India Indonesia Iran Ireland Israel Italy Jamaica Japan Korea Kuwait Lebanon Libyan Arab Jamahiriya Lithuania Luxembourg Macedonia Malaysia Mexico Morocco Netherlands New Zealand Norway Oman Pakistan Panama Paraguay Peru Philippines Poland Portugal Puerto Rico Puerto Rico Romania Russia Saudi Arabia Singapore South Africa Spain Sweden Switzerland Taiwan Thailand Trinidad Tunisia Turkey Ukraine United Aran Emirates United Kingdom Uruguay Venezuela Vietnam Yugoslavia

Quantity

5,249 (2,104 US/ 3,145 OUS)

Codes and lots

SERIAL 00000004592AW2 00000515058BU6 000000S7330007 000000M7309002 00000043494GE4 00000111595GE5 00000121784GE3 00000048049GE1 00000025782GE4 00000020959GE3 00000115777GE5 00000061266GE3 00000053396GE8 00000121783GE5 00000039991AW5 00000006077AW2 00000004473AW5 00000096726VE5 00000096716VE6 00000096588VE9 00000027640AW2 00000028924AW9 00000028941AW3 00000039721AW6 00000050165AW0 000000ANT24284 000000A7229008 000000F7334003 000000S7348002 000000F7354002 000000N8017003 000000H7352006 000000D8023004 000000D8059004 000000C8059001 000000E8081002 000000C7256009 000000G8138019 000000C7326002 000000C7326003 00000073366VE7 000000C7326001 00000028965AW2 00000027857AW2 000000ANT21808 000000Q7285002 00000531935BU5 00000050148AW6 000000M7320009 000000N8037003 000000L7302001 00000039954AW3 000000ANT21955 00000059507AW4 000000Y7296007 00000109197VE4 000000H7295003 00000027865AW5 00000006079AWB 000000Q7285001 00000027863AW0 00000531934BU8 00000014466AW7 00000014465AW9 00000005408AW0 00000028983AW5 00000514645BU1 00000039751AW3 000000ANT25242 00000039795AW0 000000L7246008 000000X7262015 000000Q7270013 000000S7297002 000000S7297003 00000031381AW7 000000A8149002 000000C8120004 000000E7331004 000000F7291002 000000F7354001 000000F7354003 000000F7354011 000000G8128007 000000H7352024 000000H8025002 000000K7360009 000000K7360010 000000L8157001 000000L8157006 000000P7338002 000000Q8030001 000000T7348006 00000004484AW2 00000004488AW3 00000004493AW3 00000004954AW4 00000005297AW7 00000006079AW8 00000013075AW7 00000013082AW3 00000013129AW2 00000013146AW6 00000027814AW3 00000027826AW7 00000027827AW5 00000027870AW5 00000027871AW3 00000029020AW5 00000029027AW0 00000031356AW9 00000031363AW5 00000031377AW5 00000052925AW5 000000L7349004 000000L7349010 000000S7348004 00000014561AW5 000000L7274001 000000B7194002 000000AC717101 000000E8067001 000000S7348001 00000004538AW5 00000005404AW9 00000028971AW0 00000028992AW6 00000004875AW1 00000012191AW3 00000005435AW3 00000013123AW5 000000H7295002 00000050176AW7 000000G8072001 000000ANT22272 00000005429AW6 00000005436AW1 00000012250AW7 000000F7354015 00000013126AW8 00000012184AW8 00000005421AW3 000000ANT21968 00000039779AW4 00000005378AW5 000000K7226001 00000004510AW4 00000004464AW4 000000H7241004 000000K7225006 00000028922AW3 00000028921AW5 00000039939AW4 00000050189AW0 000000ANT23419 00000039738AW0 00000028930AW6 00000004866AW0 00000004483AW4 000000A7229005 000000F7234010 000000C7320009 000000D7325001 000000F8161022 000000L7218004 000000L7349009 000000M7320014 000000N7226007 000000R7253009 000000X7351001 00000004959AW3 00000005354AW6 00000012190AW5 00000028987AW6 00000029016AW3 00000089780GE1 00000082598GE4 00000048844GE5 00000025573GE7 00000018522AW3 00000048840GE3 00000090888GE9 00000059999GE3 00000062424GE7 00000080390GE8 00000063052GE5 00000102649GE1 00000053890GE0 00000024451AW7 00000055773GE6 00000055783GE5 00000053883GE5 00000090086GE0 00000014128GE3 00000014122GE6 00000051987GE6 00000057182GE8 00000067821GE9 00000080512GE7…

Recall started

May 1, 2008

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

Consignees were sent a GE "Urgent Field Safety Notice" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409). Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative.

Recall number

Z-2312-2008

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

Source: FDA · Medical device enforcement report, recall number Z-2312-2008. The agency record governs; check it and the company before acting.