Recall Z-1910-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
| Date | Jul 1, 2019 (initiated May 16, 2019) |
| Status | Terminated |
| Reason | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive. |
| Root cause | Device Design |
| Action | On May 20, 2019, the firm, GE Healthcare, sent an " URGENT MEDICAL DEVICE CORRECTION" letter date 5/20/2019 to their consignees. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: discontinue use of the UV study management functionality for study split/study info updates until a correction is available and to wait for a GE representative to contact them to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service R |
| Quantity | 145 (87 US 103 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom. |
| FDA record | Open on fda.gov |