| Class 2 Device Recall Merge Hemo software | |
Date Initiated by Firm | April 04, 2016 |
Create Date | March 14, 2017 |
Recall Status1 |
Terminated 3 on August 05, 2019 |
Recall Number | Z-1457-2017 |
Recall Event ID |
76447 |
510(K)Number | K082421 |
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
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Product | Merge Hemo software.
Product Usage:
Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. |
Code Information |
Versions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3 |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
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For Additional Information Contact | Merge Service and Support 877-741-5369 |
Manufacturer Reason for Recall | In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation. |
FDA Determined Cause 2 | Software design |
Action | The recalling firm issued a letter dated March 28, 2016 via e-mail. If no email address was available, the letters were issued via certified mail. Non-responders were issued letters on July 11, 2016. The letter identified the affected product, problem and actions to be taken. For question send an email to recall@merge.com. |
Quantity in Commerce | 361 sites potentially have the affected versions |
Distribution | US Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DQK
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