Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Recall
- Recall Number
- Z-0139-2024
- Event Number
- 93099
- Firm
- GE Healthcare
- FEI Number
- 3004526608
- Product Code
- LLZ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- September 14, 2023
- Posted
- October 20, 2023
- Address
- 500 W Monroe St, Chicago, IL, 60661-3671
Description
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
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.
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
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, Vietnam
17 units