Date Initiated by Firm | May 14, 2013 |
Date Posted | May 31, 2013 |
Recall Status1 |
Terminated 3 on October 24, 2013 |
Recall Number | Z-1441-2013 |
Recall Event ID |
65191 |
510(K)Number | K121739 |
Product Classification |
Ophthalmoscope, ac-powered - Product Code HLI
|
Product | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.
Intended for in vivo imaging. |
Code Information |
iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities. |
Recalling Firm/ Manufacturer |
Optovue, Inc. 2800 Bayview Dr Fremont CA 94538-6518
|
For Additional Information Contact | William Jackson 510-623-8868 Ext. 102 |
Manufacturer Reason for Recall | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports. |
FDA Determined Cause 2 | Software design |
Action | Optovue sent a Field Correction Notice letter dated May 16, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. |
Quantity in Commerce | ~329 users |
Distribution | Distributed Nationwide and in Canada. |
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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510(K) Database | 510(K)s with Product Code = HLI
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