Recall Z-0614-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentat
| Date | Jul 14, 2016 |
| Status | Terminated |
| Reason | It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray). |
| Root cause | Software design |
| Action | Merge sent an Urgent Medical Device Recall letter dated October 19, 2016,(Recall #2016-075) to all affected customers. Initially, before it was considered a recall, the firm provided customers with a software upgrade to fix the issue. The letter described the Product, Issue, Potential Harm, Containment by the Customer/User, Action by Merge and Actions by Customers. Requested consignees to complete and return the response form. For questions email recall@merge.com. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 262-367- |
| Quantity | 29 |
| Distribution | Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053281 | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) Emageon, Inc., Dec 7, 2005 |