| Class 2 Device Recall iConnect Enterprise Archive |  |
Date Initiated by Firm | April 04, 2016 |
Date Posted | April 05, 2017 |
Recall Status1 |
Terminated 3 on June 15, 2020 |
Recall Number | Z-1762-2017 |
Recall Event ID |
76910 |
Product Classification |
Device, digital image storage, radiological - Product Code LMB
|
Product | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI. |
Code Information |
Versions : 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.1 HF0557, 8.40.s, 8.40.2.1, 8.40.2.2, 8.80, 8.80.0.1, 8.80.1.1, 8.80.2, 8.80.0.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.1.2.2, 9.2.0, 9.3.0, 9.3.1, 9.4.0, 9.4.1, 9.4.2, 9.4.2.1., and 9.4.3 |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
|
For Additional Information Contact | Merge Service and Support 877-741-5369 |
Manufacturer Reason for Recall | An error message can occur resulting in the prior studies being unavailable for viewing. |
FDA Determined Cause 2 | Software design |
Action | The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated 7/11/2016 was issued to nonresponders. |
Quantity in Commerce | 333 sites potentially have the affected versions |
Distribution | Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made. |
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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