Recall Z-1781-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
| Date | May 22, 2019 |
| Status | Terminated |
| Reason | 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 a warning displayed in the viewer. |
| Root cause | Software design |
| Action | The firm initiated their medical device correction by letter on 05/2/2019. The letter explained the problem and the safety issue and provided the following safety instructions: 1) Process Root Causes: Investigation determined that the original PACS-IW foundation design did not incorporate adequate risk mitigation for this part of the image ingestion process. DFMEA of the image ingestion wing to wing process was completed as part of the investigation, and no additional areas where further mitigations are required were identified. a) If a discrepancy is identified, attempt to retransmit the |
| Quantity | 620 units |
| Distribution | Worldwide |
| 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 |