CLARITY MEDICAL SYSTEMS INC

RETCAM 3 · General and Plastic Surgery

510(k): 0 Recall: 2 UDI: 1 MAUDE: 4 Class.: 0

Recalls (2)

Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopat

2014-03-07

One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module.

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.

2014-01-24

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.

UDI Registrations (1)

RetCam 3

RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.

MAUDE Adverse Events (4)

Untitled record

20160309

Malfunction

20140102

Malfunction