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U.S. Department of Health and Human Services

Class 2 Device Recall VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0

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  Class 2 Device Recall VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 see related information
Date Initiated by Firm May 08, 2020
Create Date June 19, 2020
Recall Status1 Terminated 3 on June 23, 2023
Recall Number Z-2403-2020
Recall Event ID 85633
510(K)Number K051649  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Code Information Merge Cardio versions 10.X and 11.X with Knowledge Base versions 3.3, 3.4, 3.5 or 5.0 installed on or before February 21, 2020.  Version 10.0 Pre-UDI Application server PN 88-00528-00; Workstation PN:88-00534-00   Version 10.1.2 Pre-UDI Application server PN 88-01075-00; Workstation PN 88-01078-00   Version 10.2 P2 Pre-UDI Application Server PN 88-01203-00   Version 10.2 P1&P2 Pre-UDI Software Release PN 87-00247-00   Version 10.3 UDI: (01) 00842000100041(10)10.3.0.1137(11)170104 Application server PN: 88-01233-00; Workstation PN 88-01239-00   Version 10.3 Patch 1 UDI: (01)00842000100041(10)10.3.0.2009(11)170309 Software Release PN 88-01319-00; Workstation PN: 88-01320-00   Version 10.3.1 UDI: (01) 00842000100041 (10) 10312135 (11) 171024 Application Server PN: 88-01426-00; Workstation PN 88-01430-00   Version 11.0.2 UDI: (01)00842000100416(10)11.0.2.1523(11)180809 Application Server Installation PN: 88-01570-00; Workstation Installation PN 88-01571-00   Version 11.0.3 UDI: (01)00842000100416(10)11.0.3.1601(11)181019 Workstation Installation PN: 88-01589-00   Version 11.1.1 UDI: (01)00842000100751(10)11.1.1(11)190724 Application Server 30-01650-00; Workstation PN:30-01654-00   
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
262-367-0700
Manufacturer Reason
for Recall		 An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.
FDA Determined
Cause 2		 Software Design Change
Action IBM Watson Health Imaging, also known as Merge Healthcare, sent an "Urgent Field Safety Notice" on May 6, 2020. The letter states that it is safe to continue to use the device as is, with the understanding that the Z-Score ranges are incorrect and should not be used to make clinical determinations. Z-Scores can be removed upon request by contacting Customer Support at the contact information below. The will provide a software correction to address the issue. A representative will be in contact with distributors to ensure all affected units have been updated. All potential users of Merge Cardio versions 10.X and 11.X with Pediatric Echo Knowledge Base with Michigan or Hybrid Z-Scores versions 3.3, 3.4, 3.5 or 5.0 should receive the notice. Customers with questions regarding the notice, please contact Customer Support at WHISupport@us.ibm.com or 877-741-5369.
Quantity in Commerce 62 units
Distribution US Nationwide distribution including in the states of IL, TX, OR, AZ, OH, TN, CA, UT, MO, GA, NM, OK, VA, IN, CT, and VT.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = CAMTRONICS MEDICAL SYSTEMS
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