GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1

FDA device recall Z-0095-2013 · posted 2012-10-19 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv

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. GE Healthcare will install new software to correct this issue with the release of Field Modification Instruction (FMI) 12129 in the near future. This correction will not affect the performance or any other functionality of your current equipment. A GE Healthcare service representative will contact you to arrange for this modification. This activity will be performed at no cost to you. 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.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

188

Distribution

Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, DC, FL, GA, KY,LA, MA, MO, NV, NJ, NY, NC, OH, OK, PA, SD, TN, TX, VA and WI., and the countries of UNITED KINGDOM, TUKEY,

Date initiated

2012-05-24

Date posted

2012-10-19

Date terminated

2013-03-26

Location

Waukesha, WI

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