GE Healthcare, LLC: Medical Device Recall in 2012 - (Recall #: Z-0125-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 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.

Product Classification:

Class II

Date Initiated: May 24, 2012

Date Posted: October 31, 2012

Recall Number: Z-0125-2013

Event ID: 61612

Reason for Recall:

GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.

Status: Terminated

Product Quantity: 12

Code Information:

000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0

Distribution Pattern:

Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN

Voluntary or Mandated:

Voluntary: Firm initiated