FDA Medical Device Recalls (openFDA)
Ge Healthcare It: GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.
- Recall number
- Z-1403-2010
- Recalling firm
- Ge Healthcare It
- Product
- GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.
- Status
- Terminated
- Initiated
- 2010-02-11
- Posted
- 2010-04-16
- Terminated
- 2010-11-15
- Reason
- There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety.
- Root cause
- Software design (manufacturing process)
- Action
- GE Healthcare issued "Urgent Medical Device Correction" notifications dated February 11, 2010. The initial notification advised users of the patient safety issues associated with the affected product. Separate letters provided the users with specific safety instructions. 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. For additional information, contact the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.
- Quantity
- 13 units
- Distribution
- Worldwide Distribution -- United States (California, Illinois, Indiana, Minnesota, Nevada, New York and Wisconsin), Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Saudi Arabia, Singapore, Switzerland, Turkey, United Arab Emirates and the United Kingdom
- Lot, serial or model codes
- Software version 1.0.0.2
- 510(k) numbers
- ["K083018"]
- 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