FDA · Medical device recall

GE Seno Advantage 1.x… and 1 more product

Nov. 26, 2010

Date posted by the FDA: Nov. 26, 2010
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion that may impact patient treatment and safety. The measurement values for GE images are not affected.
Distribution pattern: Worldwide Distribution: USA in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI,MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY, and to the countries of UNITED KINGDOM, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SOUTH, KOREA, SAUDI ARABIA , PORTUGAL, NEW ZEALAND, NETHERLANDS, KUWAIT, JAPAN, ITALY, GERMANY, FRANCE , CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, VENEZUELA, UNITED ARAB EMIRATES, THAILAND, SWEEDEN, SOUTH AFRICA, SLOVENIA, SINGAPORE, RUSSIA, PHILLIPNES, NORWAY, POLAND, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LUXEMBOURG, LEBANON, JORDAN, JAMAICA, ISRAEL, IRELAND, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUADOPUO, GREECE, GEORGIA, FINLAND, EGYPT, DOMINICAN REPUBLIC, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, BULGARIA, BOTSWANA, and ALGERIA.

2 products in this recall

GE Seno Advantage 1.x…

Product: GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1
Quantity: 2514
Codes and lots: 00000073186VE9 00000073190VE1 00000073191VE9 00000073194VE3 00000073220VE6 00000073246VE1 00000073252VE9 00000073260VE2 00000073263VE6 00000073264VE9 00000073267VE7 00000075112VE3 00000075136VE2 00000075146VE1 00000092523VE0 00000092528VE9 00000092531VE3 00000092534VE7 00000092537VE0 00000092544VE6 00000092547VE9 00000092551VE1 00000092558VE6 00000092563VE6 00000092564VE4 00000092565VE1 00000092567VE7 00000092571VE9 00000092574VE3 00000092584VE2 00000092587VE5 00000092591VE7 00000092593VE3 00000092596VE6 00000092599VE0 00000092601VE4 00000092603VE0 00000092604VE8 00000092613VE9 00000092614VE7 00000092615VE4 00000094937VE0 00000094939VE6 00000094940VE4 00000094944VE6 00000094950VE3 00000094952VE9 00000094954VES 00000094955VE2 00000094970VE1 00000102693VE9 00000102702VE8 00000102703VE6 00000102710VE1 00000102720VE0 00000102721VE8 00000102722VE6 00000102727VE5 00000102729VE1 00000102750VE7 00000102755VE6 00000102757VE2 00000102781VE2 00000103336VE4 00000103366VE1 00000425154BU2 00000425548BU5 00000425549BU3 00000449452BU2 00000487114BU1 00000487121BU6 00000487144BU8 00000487147BU1 0000FRB4050CPR 0000FRB4240CMQ 0000FRB43705LG 11 00000092529VE7 00000092543VE8 00000092545VE3 00000092557VE8 00000092559VE4 00000092560VE2 00000092562VE8 00000092569VE3 00000092570VE1 00000092576VE8 00000092582VE6 00000092583VE4 00000092588VE3 00000092589VE1 00000092592VE5 00000092594VE1 00000092597VE4 00000092612VE1 00000092617VE0 00000094935VE4 00000094938VE8 00000094946VE1 00000094954VE5 00000094963VE6 00000094973VE5 00000102686VE3 00000102715VE0 00000102716VE8 00000102718VE4 00000102725VE9 00000102732VE5 00000102743VE2 00000103333VE1 00000103359VE6 00000103360VE4 00000103365VE3 00000103368VE7 00000103371VE1 00000103375VE2 00000103376VE0 00000103378VE6 00000103399VE2 00000103400VE8 00000103406VE5 00000103408VE1 00000092539VE6 00000102746VE5 00000102766VE3 00000102772VE1 00000102774VE7 00000428047BU5 00000102683VE0 00000102691VE3 00000102726VE7 00000102777VE0 00000102778VE8 00000103340VE6 00000103363VE8 00000487118BU2 00000092549VE5 00000092521VE4 00000092581VE8 00000094941VE2 00000102764VE8 00000103350VE5 00000102717VE6 00000425546BU9 00000075121VE4 00000087617VE7 00000094943VE8 00000102739VE0 00000103370VE3 00000073189VE3 00000073208VE1 00000073221VE4 00000073224VE8 00000073237VE0 00000073251VE1 00000073253VE7 00000073261VE0 00000073262VE8 00000073271VE9 00000073281VE8 00000075110VE7 00000075118VE0 00000075147VE9 00000092542VE0 00000092550VE3 00000092555VE2 00000092595VE8 00000092605VE5 00000092609VE7 00000094958VE6 00000094971VE9 00000102706VE9 00000102714VE3 00000102719VE2 00000102736VE6 00000102738VE2 00000102742VE4 00000102769VE7 00000102773VE9 00000102780VE4 00000103341VE4 00000103342VE2 00000103349VE7 00000103354VE7 00000103356VE2 00000103401VE6 00000103403VE2 00000103404VE0 00000103405VE7 00000103407VE3 00000103414VE9 00000103417VE2 00000425547BU7 00000102697VE0 00000092540VE4 00000092610VE5 00000094949VE5 00000094965VE1 00000102735VE8 00000102779VE6…
Recall started: Aug. 28, 2009
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: GE Healthcare issued "Urgent Medical Device Correction" letters dated August 28, 2009 or August 31, 2009 to either Seno Advantage Customers (Hospital Administrators/Risk Mangers, Radiology Department Managers), and Image Diagnostic Customers (Hospital Administrators/Risk Managers, Radiology Department Managers). The letters described the Safety Issue, Affected Product Details, safety Instructions, Product correction and Contact Information. GE will linstall new software with the release of Field Modification Instruction 12129. Customers can contact GE Healthcare about this issue at 800-437-1171.
Recall number: Z-0476-2011

GE Healthcare IDI Mammo Workstation

Product: GE Healthcare IDI Mammo Workstation
Quantity: 158
Codes and lots: Serial Number 000000B9006010 000000B9006027 000000B9006007 000000B9106009 000000A9008014 000000A8192017 000000A8192028 000000A8192021 000000A8192023 000000A9008008 000000K8302001 000000K8302002 000000A9008023 000000A9008020 000000D9105019 000000A9008015 000000A8192020 000000A8192030 000000A8192005 000000A9008021 000000B9006003 000000A8192004 000000A8192002 000000A9008012 000000D8319003 000000A9008001 000000D9105004 000000A8192016 000000A8192025 000000A9008007 000000A9008025 000000A8192007 000000D9105018 000000E9036005 000000D9105020 000000D9105017 000000A9008002 000000A8192013 000000A9008003 000000E9036002 000000B9006021 000000B9006008 000000B9006025 000000B9006023 000000B9006004 000000E9036016 000000A8192026 000000E9036011 000000B9006024 000000A9008022 000000E9036012 000000E9036014 000000A9008013 000000A9008026 000000E9036015 000000D9105016 000000D9105021 000000E9036007 000000E9036017 000000A8192018 000000A9008004 000000A8192008 000000A8192019 000000A8192027 System ID 914632IDI 419294RS 402443SIDIWS 815730IDI AP5861WS01 197824RX01 220078RX32 529010WS02 529010CO01 529010WS03 437918WS02 437918WS03 610825WS01 610742WS01 475120WS01 475410WS01 PC0231WS01 584139WS01 HC5284WS06 HC5284WS03 UE282657 UE278A07 ME208358 UE226243 UE260517 UE825434 GEC21857 UE929512 UE720416 M4484977 M4185534 M191922004 M191922005 M4144348 M4143969 M4143967 M4143968 M4143970 00249IDI01 IE1513ID01 01245IDI01 00374IDI01 10598IDI03 10598IDI01 10598IDI02 10598IDI04 10598IDI05 00440IDI01 10351IDI01 00231IDI03 00379IDI01 00132IDI01 10602IDI01 10344IDI02 00356IDI01 00356IDI02 00273IDI01 00230IDI02 00230IDI01 00436IDI02 00313IDI01 00313IDI02 A5738904 A5110284 WIN0105 WIN0103 IN20070124-171 IN20060802-113 IN20060802-48 IN20071015-316 IN20071119-334 IN20071119-335 IN20060802-84 IN20071002-306 IN20070211-189 IN20070601-224 IN20071026-325 IN20070515-222 IN20060802-69 IN20071002-308 IN20071002-309 IN20070323-201 IN20070323-200 IN20070323-206 IN20070806-278 IN20070907-293 IN20080428-371 IN20070614-228 IN20070413-216 IN20060810-133 IN20060802-115 IN20060802-72 IN20060802-89 IN20071005-312 IN20080808-383 IN20081212-421 IN20060717-34 IN20060719-38 IN20071029-327 IN20071105-328 IN20071105-329 IN20070809-285 IN20070809-286 IN20060802-95 IN20060802-102 IN20060802-121 IN20070628-233 IN20070628-234 IN20070628-235 IN20070628-236 IN20080923-396 IN20071129-340 IN20071024-324 IN20080314-355 IN20080314-356 IN20080314-357 IN20070606-226 IN20060802-67 IN20060802-68 IN20070614-227 IN20080326-358 IN20081017-413 IN20080407-361 IN20080407-362 IN20080407-363 IN20080407-364 IN20080407-365 IN20060717-32 IN20081023-414 IN20061101-148 IN20060802-104 IN20081204-417 IN20060802-109 IN20060802-126 IN20060802-96 IN20061209-153 IN20060802-82 IN20090617-542 IN20080515-372 IN20070219-192 IN20080222-351 IN20060713-29 IN20081212-420 IN20090707-555 IN20080813-387 IN20080813-388 IN20080813-389 IN20071221-342 IN20060802-42 IN20070809-284 IN20060802-49 IN20060802-47 IN20090415-493 IN20100211-672 IN20081222-426 IN20061205-152…
Recall started: Aug. 28, 2009
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: GE Healthcare issued "Urgent Medical Device Correction" letters dated August 28, 2009 or August 31, 2009 to either Seno Advantage Customers (Hospital Administrators/Risk Mangers, Radiology Department Managers), and Image Diagnostic Customers (Hospital Administrators/Risk Managers, Radiology Department Managers). The letters described the Safety Issue, Affected Product Details, safety Instructions, Product correction and Contact Information. GE will linstall new software with the release of Field Modification Instruction 12129. Customers can contact GE Healthcare about this issue at 800-437-1171.
Recall number: Z-0477-2011

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0476-2011, Z-0477-2011. The agency record governs; check it and the company before acting.

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