Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Merge LIS software

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Merge LIS software see related information
Date Initiated by Firm March 05, 2015
Create Date November 11, 2016
Recall Status1 Terminated 3 on April 12, 2019
Recall Number Z-0399-2017
Recall Event ID 75419
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Merge LIS software.
Code Information Versions: 4.0.1 and earlier.
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service & Support
877-741-5369
Manufacturer Reason
for Recall		 There is a potential for duplicate container numbers to be created for patients.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. If no email address was available, the letters were issued via certified mail. Letters to nonresponders were issued 5/26/2016.
Quantity in Commerce 413 sites potentially have the affected software
Distribution Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.
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.
-
-