Z-0024-2013 Class II Terminated
FDA device recall Z-0024-2013 was initiated by Optovue Inc. on September 7, 2012 and is designated Class II. 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 Metho… The recall status is terminated (terminated March 4, 2013). Affected quantity: 795 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2012
- Initiation Date
- September 7, 2012
- Termination Date
- March 4, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
Distribution Pattern
Worldwide Distribution -- USA (nationwide) and Internationally.
Code Information
All units of these models.