Date Initiated by Firm | May 24, 2017 |
Create Date | June 22, 2017 |
Recall Status1 |
Terminated 3 on June 28, 2019 |
Recall Number | Z-2620-2017 |
Recall Event ID |
77265 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | Merge 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
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For Additional Information Contact | Merge 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 |
Action | The 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 Commerce | 98 sites potentially have the affected versions |
Distribution | Distribution was made nationwide to medical facilities. There was no foreign/government/military 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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