Date Initiated by Firm | January 30, 2016 |
Create Date | November 28, 2016 |
Recall Status1 |
Terminated 3 on March 20, 2019 |
Recall Number | Z-0664-2017 |
Recall Event ID |
75334 |
Product Classification |
Medical device data system - Product Code OUG
|
Product | Merge FlexConnect software, a component of Merge LIS.
Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications |
Code Information |
Version 1.0 |
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 | Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software. |
FDA Determined Cause 2 | Software design |
Action | The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. Nonresponders were issued a second letter dated 5/25/2016 via email on 5/26/2016. |
Quantity in Commerce | 324 sites potentially have the affected version |
Distribution | 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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