Recall Z-1302-2018 ยท LLZ System, Image Processing, Radiological
GE Healthcare
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
| Date | Feb 23, 2018 |
| Status | Terminated |
| Reason | A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series. |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated February 23, 2018 to their customers. The letter provided the affected product, problem and provided the following safety instructions: "Until a product modification is available to correct this issue, the following actions are recommended: 1. Utilize the image count within the QC process to alert the user of a discrepancy in the number of transmitted images from the modality to the number of images available in the Universal Viewer. a. If a discrepancy is identified, attempt to retransmit the exam to PACS. b. If retrans |
| Quantity | 569 units |
| Distribution | Worldwide Distribution-US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082318 | CENTRICITY PACS IW Ge Healthcare Dynamic Imaging Solutions, Aug 25, 2008 |