FDA-Device2014-03-26Class II
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 retinopathy of prematurity or treatment requiring ROP.
Clarity Medical Systems Inc
Hazard
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.
Sold states
Worldwide Distribution: US (nationwide) to states of: TN, MA, CA, TX, MD,FL, MS, IL, and PA; and to countries of: France, Thailand, Egypt, Mexico, Kuwait, India, Austria,Japan, Sweden, Peru, United Kingdom, Philippines,The Netherlands, China,, UAE,Israel, Germany, Italy.
Affected count
234 lamps
Manufactured in
5775 W Las Positas Blvd Suite 200, Pleasanton, CA, United States
Products
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 retinopathy of prematurity or treatment requiring ROP.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1265-2014Don't want to check this manually?
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