Recall Z-1911-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
| 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 | 92 (47 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 |
510(k) clearances named in this recall
| K110875 | CENTRICITY PACS GE Healthcare, May 5, 2011 |