GE Healthcare…

Date posted by the FDA

Aug. 12, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

Reason

GE Healthcare has become aware that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This issue may impact patient safety. When Seno Advantage workstation is synchronized with RIS using CCOW (an HL7 standard protocol designed to enable disparate applications to synchronize in real-time), the following issues could occur: 1. Two different

Distribution pattern

Worldwide Distribution--USA (nationwide) including the states of: AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OK, OR, PA, SC, TN,TX, and WI, and the countries of UNITED KINGDOM, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, PORTUGAL NORWAY, NEW ZEALAND, LUXEMBOURG, LEBANON, KOREA, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, DENMARK, CANADA, BELGIUM AUSTRIA, AUSTRALIA FINLAND.

Quantity

391

Codes and lots

00000112926GE1 00000114903GE8 00000099996GE1 00000090034GE0 00000106421GE1 00000099995GE3 00000099999GE5 00000142841GE6 00000075247GE7 00000090027GE4 00000090035GE7 00000112124GE3 00000090028GE2 00000128524GE6 00000123805GE4 00000084251GE8 00000090032GE4 00000090030GE8 00000114902GE0 00000114904GE6 00000114907GE9 00000103152GE5 00000142833GE3 00000117138GE8 00000126080GE1 00000106426GE0 00000114091GE2 00000128525GE3 00000106422GE9 00000106423GE7 00000112122GE7 00000112123GE5 00000123807GE0 00000117141GE2 00000123803GE9 00000123804GE7 00000142832GE5 00000136611GE1 00000128528GE7 00000126081GE9 00000132306GE2 00000126082GE7 00000132314GE6 00000142835GE8 00000142837GE4 00000142839GE0 00000142836GE6 00000147369GE3 00000149799GE9 00000154940GE1 00000158811GE0 00000158814GE4 00000164500GE1 00000165231GE2 00000166279GE0 00000180129GE9 00000180127GE3 00000166280GE8 00000174024GE0 00000166281GE6 00000177327GE4 00000174026GE5 00000174027GE3 00000166282GE4 00000195402GE3 00000195403GE1 00000080399GE3 00000177331GE6 00000179272GE0 00000179273GE8 00000179274GE6 00000179281GE1 00000179282GE9 00000188371GE9 00000193278GE9 00000114088GE8 00000114089GE6 00000195401GE5 00000206492GE1 00000206491GE3 00000200440GE6 00000190780GE7 00000106427GE8 00000200442GE2 00000128529GE5 00000090033GE2 00000170113GE2 00000218674GE0 00000218675GE7 00000220618GE3 00000158410GE1 00000158809GE4 00000103151GE7 00000080399GE9 00000090026GE6 00000132309GE6 00000106424GE5 00000106425GE2 00000114905GE3 00000154938GE5 00000126078GE5 00000126079GE3 00000119930GE6 00000119931GE4 00000114906GE1 00000132310GE4 00000136608GE7 00000136609GE5 00000136610GE3 00000142838GE2 00000152337GE2 00000174023GE2 00000158810GE2 00000166277GE4 00000164502GE7 00000164503GE5 00000164504GE3 00000158812GE8 00000158813GE6 00000165228GE8 00000165229GE6 00000166278GE2 00000180131GE5 00000180132GE3 00000193275GE5 00000193276GE3 00000179278GE7 00000200441GE4 00000206489GE7 00000179275GE3 00000179279GE5 00000180128GE1 00000179280GE3 00000195404GE9 00000195405GE6 00000206490GE5 00000212965GE8 00000212966GE6 00000212967GE4 00000114092GE0 00000114093GE8 00000114094GE6 00000114095GE3 00000164501GE9 00000149802GE1 00000149801GE3 00000165230GE4 00000180130GE7 00000117140GE4 00000117137GE0 00000165227GE0 00000114090GE4 00000117136GE2 00000114908GE7 00000126077GE7 00000132307GE0 00000132308GE8 00000132315GE3 00000136604GE6 00000142834GE1 00000152336GE4 00000193277GE1 00000119932GE2 00000119933GE0 00000149803GE9 00000218673GE2 000000Y8350001 000000F9097001 000000R9058001 00000H10238001 00000T10230001 000000R8221001 000000C8140001 00000V11063002 000000J8147001 000000S8135001 00000ZA9233001 00000J10019001 000000G9278001 00000D10166001 000000S8340001 000000Q8352001 000000T8353001 000000Y8350002 00000N10193003 00000G10337001 000000ANT23042 000000ANT23043 000000ANT25610 000000ANT25612 000000U7164002 0000AB11012001 0000AB11012002 00000M11006003 000000T7323001 000000S9232001 00000V10329001 00000G10264001 00000D10333001 00000J10209001…

Recall started

May 31, 2011

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent a URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated May 31, 2011. The letter identified the product , the problem and the action needed to be taken by the customer. GE Healthcare will upgrade all affected workstations at no cost. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative

Recall number

Z-3012-2011

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

Source: FDA · Medical device enforcement report, recall number Z-3012-2011. The agency record governs; check it and the company before acting.