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.
FDA Recall Z-1403-2010 · Posted 2010-04-16
Recalling FirmGe Healthcare It
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-02-11
Date Terminated2010-11-15
Product Quantity13 units
Reason for Recall
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.
Firm 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.
Root Cause
Software design (manufacturing process)
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.