FDA Medical Device Recalls (openFDA)
GE Healthcare Integrated IT Solutions: GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
- Recall number
- Z-1826-2008
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Product
- GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
- Status
- Terminated
- Initiated
- 2008-05-06
- Posted
- 2008-09-02
- Terminated
- 2010-02-03
- Reason
- A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
- Root cause
- Software design
- Action
- GE Healthcare IITS sent Product Safety Notification letters dated 5/5/08 to all customers who have the GE Centricity PACS Software Versions 3.0.0.X, 3.0.1.X, 3.0.2.X and 3.0.3.X informing them of the incorrect study date and time information being displayed in the report screen and title, which may lead to a potential patient misdiagnosis. The users were instructed to refer to the image overlay for the correct date and time until the new software version can be installed. A software patch to permanently resolve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.
- Quantity
- 177 units
- Distribution
- Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Malta, South Korea, Spain, Switzerland and United Kingdom.
- Lot, serial or model codes
- GE Centricity PACS RA1000 Workstation software version: 3.0.0.X, 3.0.1.X, 3.0.2.X, and 3.0.3.X
- 510(k) numbers
- ["K043415"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3004526608
- Firm city
- Barrington
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28