Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Optovue RTVue, iVue

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Optovue RTVue, iVue see related information
Date Initiated by Firm September 07, 2012
Date Posted October 09, 2012
Recall Status1 Terminated 3 on March 04, 2013
Recall Number Z-0024-2013
Recall Event ID 63211
510(K)Number K101505  K091404  
Product Classification Tomography optical coherence - Product Code OBO
Product Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100;
The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA

The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.


Code Information All units of these models.
Recalling Firm/
Manufacturer		 Optovue Inc.
2800 Bayview Dr
Fremont CA 94538-6518
For Additional Information Contact Azimun Jamal
510-623-8868 Ext. 102
Manufacturer Reason
for Recall		 Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.
FDA Determined
Cause 2		 No Marketing Application
Action Optovue Inc., sent a Voluntary Field Correction and Removal letter dated September 6, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer . Please sign and return the attached form indicating your acknowledgement that that the Affected Materials have been returned or destroyed. If you have any further questions please contact Optovue, at 1-866-344-8948.
Quantity in Commerce 795 units
Distribution Worldwide Distribution -- USA (nationwide) and Internationally.
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 = OBO and Original Applicant = OPTOVUE, INC.
-
-