Recall Z-0928-2009 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, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinic
| Date | Jan 27, 2009 (initiated Nov 21, 2008) |
| Status | Terminated |
| Reason | There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed. |
| 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 11/21/08 of the software anomaly resulting in a patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed. The letter provided the users with safety instructions to follow until the software is updated. Please direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclose |
| Quantity | 476 units |
| Distribution | Worldwide Distribution including USA and country of Canada. |
| 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 |