Date Initiated by Firm |
April 04, 2016 |
Date Posted |
March 13, 2017 |
Recall Status1 |
Terminated 3 on June 22, 2020 |
Recall Number |
Z-1681-2017 |
Recall Event ID |
76309 |
510(K)Number |
K110006 K913929
|
Product Classification |
System, image management, ophthalmic - Product Code NFJ
|
Product |
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). |
Code Information |
All versions of Eye Care PACS, Eye Station, and ESIU. |
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 |
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
|
FDA Determined Cause 2 |
Software Design Change |
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. |
Quantity in Commerce |
1,627 sites potentially have the affected software |
Distribution |
Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution. |
Total Product Life Cycle |
TPLC 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.
|
510(K) Database |
510(K)s with Product Code = NFJ and Original Applicant = OPHTHALMIC IMAGING SYSTEMS
|