Z-0970-2009

GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions...

Name: Z-0970-2009 GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions...
Creator: GE Healthcare Integrated IT Solutions
Published: 2008-11-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-11-20 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS... on 2008-11-20. The reason FDA records is "Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam". 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-0970-2009
Status: Terminated
Initiated: 2008-11-20
Posted: 2009-02-03
Terminated: 2010-02-03
Recalling firm: GE Healthcare
Product: GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation with Talk Extend software customers via letter (Urgent Medical Device Correction) dated 11/10/08 of the software anomaly resulting in a patient safety issue involving Talk Extend, which could contribute to a delay of care or misdiagnosis due to delay in communicating pertinent exam results or failure to treat due to lack of an attached dictated report by the radiologist for physician review. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.
Quantity in commerce: 22 units
Distribution: California, Florida, Illinois, Iowa, Louisiana, Oregon, Pennsylvania, Texas, Utah, Virginia and Wisconsin.
Product codes and lots: Software versions 2.1.X and 3.0.X and higher with Talk Extend

Product code LLZ

K043415Class IICentricity Pacs SystemGe Medical Systems Information Technologies / cleared 2005-01-21

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)