Recall Z-2944-2020 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS
| Date | Aug 6, 2020 |
| Status | Terminated |
| Reason | Measurements done on the Merge PACS generated MPR s may have incorrect measurements. |
| Root cause | Software design |
| Action | The firm, IBM Watson Health, sent an "Urgent Field Safety Notice" dated 05 August 2020 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: Avoid incorrect pixel measurements by using the following workflow: Step 1: Modality acquires a series and generates reformat and sends to Merge PACS Step 2: Radiologist performs measurement on these series from the modality. Avoid black dots that may lead to additional imaging by taking any of the following actions: - Verifying study images either at modal |
| Quantity | 125 total units |
| Distribution | Domestic Distribution: IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN. International Distribution: CA, BE, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192455 | Merge PACS Merge Healthcare Incorporated, Oct 17, 2019 |