Recall Z-0034-2014 ยท LLZ System, Image Processing, Radiological
GE Healthcare It
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or acro
| Date | Oct 21, 2013 (initiated Oct 2, 2012) |
| Status | Terminated |
| Reason | GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Curr |
| Root cause | Software design |
| Action | GE Healthcare IT mailed an IMPORTANT PRODUCT INFORMATION letter dated October 2, 2012 to the only consignee of this product. The letter notified the customer of the issue, provided temporary instructions on how to use safely use the software until a new software version can be installed, and advises that a software correction will be made available in the near future. Customers who have any questions can contact their local GEHC-IT service representative or call GE Healthcare's Remote Online Center (ROC) Customer Care Center at 1-800-437-1171. |
| Quantity | 1 unit |
| Distribution | USA Nationwide Distribution in the state of OK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112570 | CENTRICITY CARDIO IMAGING Ge Healthcare Integrated IT Solutions, Nov 30, 2011 |