Z-1960-2012Class II

GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2...

Name: Z-1960-2012 GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2...
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 Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage... on 2012-05-24. FDA classified it as Class II and gives the reason as "GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume...". 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-1960-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-24
Posted: 2012-07-09
Terminated: 2012-12-06
Recalling firm: GE Healthcare
Product: GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET).
Product code: LLZ System, Image Processing, Radiological
Reason for recall: GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides safety instructions for customers to use until a software upgrade is available. Contact the firm at 800-437-1171 for questions regarding this recall.
Quantity in commerce: 70
Distribution: Worldwide Distribution-USA (nationwide) including the states of CA, FL, IL, MA, NJ, NY, SC, and TX and the countries of TURKEY, TUNISIA, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, KENYA, JAPAN, ITALY, IRELAND, INDIA, GREAT BRITAIN, GERMANY, FRANCE, EGYPT, CHILE, CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, and ARGENTINA.
Product codes and lots: 261AWUSV35007H7 10026AW 514934BAR14 26329AW2 ACBCTAW7 956632AW42 321799AW1 617355AWPC1 617355AW3 361595SKW1 617754MR5AW 3454AWW 3526 941747AWW 212639XL5 239436AW2 773792AW1 803366AW1 813642AW42 973972AWW3 973972AWW5 210292AW41C 082445030001AW 082445010004AW 082421010160AW 082421120176AW 082406200003AW 082421150050AW 082416130012AW 082445150008AW 082421100265AW 082421050047AW 083049822101584 083055602101433 083055065231713 083049842101695 PT0004 PT0023 0847490042 0853550153 0853550221 AH4511AW01 030070OT02 EG1277AW01 M4017059 PC0125AW02 PC0815AW03 PC0362AW04 IE1005AW02 A5248812 A5158021 A5226504 KE1000AW01 RU2441AW02 SA1054AW01 NP083626 MP825712 FPG72503 0853550150 TN1003AW02 06056DCS01 70001ADW06 00327ADW01 58831121222 L0235B396 321mraw 420686AW01 B4192933 CC0618AW04 M27534

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1960-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1960-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

Product code LLZ

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)