Recall Z-0139-2024 ยท LLZ System, Image Processing, Radiological
GE Healthcare
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
| Date | Oct 20, 2023 (initiated Sep 14, 2023) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation. |
| Root cause | Software design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/14/2023 by letter. The notice explained the problem, risk to the patient, and provided two workaround options for the continued use of the instruments until the software update is ready for installation. Questions: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative |
| Quantity | 17 units |
| Distribution | US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Viet |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123174 | CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE Healthcare, Nov 16, 2012 |