Recall Z-1214-2015 ยท LLZ System, Image Processing, Radiological
GE Healthcare
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 clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipul
| Date | Feb 26, 2015 (initiated Feb 18, 2013) |
| Status | Terminated |
| Reason | Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp |
| Root cause | Software design |
| Action | Consignees were notified of the issue via telephone and site visit by GE Healthcare IT Field Engineers. |
| Quantity | 128 systems |
| Distribution | Distributed US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV, and the country of Bermuda. |
| 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 |