Recall Z-1394-2010 ยท LLZ System, Image Processing, Radiological
Ge Healthcare It
GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
| Date | Apr 15, 2010 (initiated Feb 18, 2010) |
| Status | Terminated |
| Reason | There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers. |
| Root cause | Software design |
| Action | An "Urgent Medical Device Correction" letters dated February 18, 2010 to their Centricity PACS-IW software version 3.x customers and Centricity PACS Web Diagnostic software version 3.7.4.x customers, The letters advised the users of the patient safety issues associated with the use of the software when using built-in reconstruction functions, which may result in incorrect anatomic orientation markers. The separate letters provided the users with specific safety instructions for that software version to follow until the software is updated. The customers were requested to complete the enclose |
| Quantity | 634 units |
| Distribution | Worldwide distribution: USA and Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korean, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Netherlands, Philippines, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082318 | CENTRICITY PACS IW Ge Healthcare Dynamic Imaging Solutions, Aug 25, 2008 |