Recall Z-1885-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals.
| Date | May 17, 2019 |
| Status | Terminated |
| Reason | There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. |
| Root cause | Software design |
| Action | The firm issued a medical device correction notice on 05/17/2019. The letter stated the safety issue and provided additional instructions on the use of the system until a service engineer installs the correction. A firm representative will contact the consignee to arrange for the installation. |
| Quantity | 50 units |
| Distribution | Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdom Uruguay |
| 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 |