Class 2 Device Recall IDI Mammo Workstation

• Date Initiated by Firm: August 28, 2009
• Date Posted: November 26, 2010
• Recall Status: Terminated on June 05, 2012
• Recall Number: Z-0477-2011
• Recall Event ID: 57077
• 510(K)Number: K0811630
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: GE Healthcare IDI Mammo Workstation
• Code Information: 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 IN20080923-398 IN20100309-707
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-513-4122
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 158
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.