Z-1104-2008

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

Name: Z-1104-2008 GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions...
Creator: GE Healthcare Integrated IT Solutions
Published: 2007-12-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-12-28 / 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 on 2007-12-28. The reason FDA records is "Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe...". 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-1104-2008
Status: Terminated
Initiated: 2007-12-28
Posted: 2008-05-01
Terminated: 2010-05-17
Recalling firm: GE Healthcare
Product: GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare IITS sent Product Safety Notification letters dated 12/28/07 to all customers who have the GE Centricity PACS RA1000 Workstation software versions 2.1.X, or 3.0.X, informing them of the potential patient safety issue involving the exam notes window, which may be used to provide various patient information including lab results. To mitigate this problem, the users were instructed not to use the following four special characters (greater than sign >, less than sign <, double quotation mark " and apostrophe ') in the exam notes field in order to prevent any adverse patient events. For example, if a lab result was entered as GFR <60, it should be typed as GFR less than 60. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the problem and the recommended actions provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.
Quantity in commerce: 557 units
Distribution: Worldwide Distribution - USA, Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, New Zealand, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
Product codes and lots: GE Centricity PACS RA1000 Workstation Software versions 2.1.X. and 3.0.X.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)