Recall Z-0836-2009 ยท LLZ System, Image Processing, Radiological
GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation i
| Date | Jan 23, 2009 (initiated Dec 12, 2008) |
| Status | Terminated |
| Reason | There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it. |
| Root cause | Software design |
| Action | GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomaly resulting in a patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center |
| Quantity | 138 units |
| Distribution | Worldwide Distribution including USA and countries of Canada, China, Denmark, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Saudi Arabia, Spain, Taiwan and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043415 | CENTRICITY PACS SYSTEM Ge Medical Systems Information Technologies, Jan 21, 2005 |