Z-1782-2017Class II

Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives...

Name: Z-1782-2017 Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives...
Creator: Ge Medical Systems Information T
Published: 2013-02-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-02-18 / Terminated / root cause: software

FDA source

Ge Medical Systems Information T began a recall of Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from... on 2013-02-18. FDA classified it as Class II and gives the reason as "It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the...". 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-1782-2017
Classification: Class II
Status: Terminated
Initiated: 2013-02-18
Posted: 2017-04-11
Terminated: 2017-07-31
Recalling firm: GE Healthcare
Product: Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
Root cause tag: software
FDA root cause: Software design
Action: Firm sent notification letter to all impacted customer accounts. The letter provided the following instructions for customers to follow until the permanent fix for the issue was deployed: 1) The users should be instructed to look at the date on each exam displayed rather than just the labels assigned to the exam by the system. 2) If this problem is detected in your specific workflows, a system administrator can remove the study category labels (Current/Prior/Baseline)from all overlays on the images/exams. A software code change was deployed to customer sites to correct the issue.
Quantity in commerce: 118
Distribution: Nationwide, Worldwide
Product codes and lots: Versions 1.0, 1.1, 2.0, 2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1782-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1782-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11

Product code LLZ

K083018Class IICentricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions / cleared 2008-11-14

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)