Merge Healthcare, Inc. Merge PACS Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

Recommended Action

Per FDA guidance

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 modality or in another viewer. - Increasing the window level will window out the lowest pixel value (the black dots). - Viewing additional images/series within the study. Viewing of prior series/studies. - Verifying patients history, diagnosis or other clinical data. IBM Watson Health/Merge Healthcare will provide a software correction to address these issues. A representative will be in contact with you to schedule the software update. Please ensure all potential users of Merge PACS v8.1, 8.1.1 and 8.1.2 have received this notice. Please provide this notice to other organizations impacted by this action. If you have any questions regarding this notice, please contact Customer Support at WHISupport@us.ibm.com or 877-741-5369.

Distribution

As reported by FDA

AR, CA, CT, DE, FL, GA, IL, IN, MD, MI, MN, MS, MO, NE, NH, NM, NY, NC, ND, OH, SC, TX, UT, VA, WI