Recall Z-1402-2010 ยท LLZ System, Image Processing, Radiological
Ge Healthcare It
GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.
| Date | Apr 16, 2010 (initiated Feb 11, 2010) |
| Status | Terminated |
| 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 | 29 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 |
| 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 |