Medical Device Recall: Z-0024-2013

FDA Recalls dataset · Firm: Optovue Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2012-09-07 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0024-2013.

Recall Res Number
Z-0024-2013
Recalling Firm / Manufacturer
Optovue Inc.
FEI Number
3005950902
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2012-09-07
Date Posted
2012-10-09
Date Terminated
2013-03-04
Product Code
OBO
Event Number
63211
Product Quantity
795 units
Product Description 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.
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.
Action Details 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.
Distribution Pattern Worldwide Distribution -- USA (nationwide) and Internationally.
Code Information / Serial Numbers All units of these models.

Related Establishments / Registrations

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