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U.S. Department of Health and Human Services

Class 2 Device Recall Merge OrthoPACS

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 Class 2 Device Recall Merge OrthoPACSsee related information
Date Initiated by FirmMay 24, 2017
Create DateJune 22, 2017
Recall Status1 Terminated 3 on June 28, 2019
Recall NumberZ-2620-2017
Recall Event ID 77265
Product Classification System, image processing, radiological - Product Code LLZ
ProductMerge OrthoPACS software.
Code Information Versions 6.6, 6.6.1, and 6.6.2
Recalling Firm/
Manufacturer
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information ContactMerge Service and Support
877-741-5369
Manufacturer Reason
for Recall
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
FDA Determined
Cause 2
Software design
ActionThe recalling firm issued a letter dated 5/19/2017 via email on 5/24/2017 or via certified mail if they did not have an email address for the customer.
Quantity in Commerce98 sites potentially have the affected versions
DistributionDistribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
Total Product Life CycleTPLC 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.
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