Z-0125-2013Class II

GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review...

Name: Z-0125-2013 GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review...
Creator: GE Healthcare, LLC
Published: 2012-05-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-05-24 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of 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... on 2012-05-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0125-2013
Classification: Class II
Status: Terminated
Initiated: 2012-05-24
Posted: 2012-10-24
Terminated: 2012-12-11
Recalling firm: GE Healthcare
Product: 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 code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were sent on 5/24/12 a GE Healthcare "Urgent Medical Device Correction" letter dated May 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. Customers should verify if their workstation is affected. GE Healthcare will correct all affected workstations by providing a software upgrade and Operator Manual update. A GE Healthcare service representative will contact you to arrange this correction. 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.
Quantity in commerce: 12
Distribution: Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN
Product codes and lots: 000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0125-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24

Product code LLZ

K033400Class IISeno AdvantageGe Medical Systems W-400 / cleared 2003-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)