Company:Elekta, Inc.
Date of Enforcement Report:3/19/2014
Class lI:
PRODUCT
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging. RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
Recall Number Z-1154-2014
REASON
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly..
RECALLING FIRM/MANUFACTURER
Clarity Medical Systems Inc., Pleasanton, CA. on 1/24/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.
DISTRIBUTION
Nationwide and Internationally
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