Optovue, Inc. recalls

4 recalls on record · latest: July 27, 2017

Official U.S. recall history for Optovue, Inc., compiled from official government records.

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Optovue, Inc. recalls iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging devic…

July 27, 2017 · Medical device recalls Moderate risk FDA determined that a 510(k) is needed for the Vault Mapping software (also kno…

Optovue, Inc. recalls iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high r…

July 27, 2017 · Medical device recalls Moderate risk FDA determined that a 510(k) is needed for the Vault Mapping software (also kno…

Optovue, Inc. recalls iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vi…

July 27, 2017 · Medical device recalls Moderate risk FDA determined that a 510(k) is needed for the Vault Mapping software (also kno…

Optovue, Inc. recalls iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of…

March 16, 2016 · Medical device recalls Moderate risk A software anomaly was detected that affects Optovue iVue and iVue 500 with Nor…