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U.S. Department of Health and Human Services

Class 2 Device Recall Merge PACS

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  Class 2 Device Recall Merge PACS see related information
Date Initiated by Firm August 06, 2020
Create Date September 09, 2020
Recall Status1 Open3, Classified
Recall Number Z-2944-2020
Recall Event ID 86205
510(K)Number K192455  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge PACS
Code Information Unique Device Identifier (UDI): v8.1:  PACS:(01)00842000100805(10)8.1(11)191022 OrthoPACS: (01)00842000100805(10)8.1(11)191022 v81.1:  PACS: (01)00842000100805(10)8.1.1(11)200528 OrthoPACS: (01)00842000100805(10)8.1.1(11)200528  V8.1.2  PACS: (01)00842000100805(10)8.1.2(11)200709
Recalling Firm/
Manufacturer
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Todd Brill
262-367-0700
Manufacturer Reason
for Recall
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = Merge Healthcare Incorporated
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