Events

Recall of Device Recall IDI Mammo Workstation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57077
  • Event Risk Class
    Class 2
  • Event Number
    Z-0477-2011
  • Event Initiated Date
    2009-08-28
  • Event Date Posted
    2010-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95331
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • 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.
  • 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.

Device

Device Recall IDI Mammo Workstation
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    GE Healthcare IDI Mammo Workstation
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA