GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume An

FDA device recall Z-0901-2013 · posted 2013-03-01 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.

Action taken

GE Healthcare sent a "Urgent Medical Device Correction " letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the Edit Contour feature until this software functionality is corrected or replaced. GE Healthcare will correct all affected systems by providing a software upgrade at no cost to you. 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. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

363

Distribution

Worldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRAL

Date initiated

2012-05-25

Date posted

2013-03-01

Date terminated

2014-01-28

Location

Waukesha, WI

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