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.
FDA Recall Z-1265-2014 · Posted 2014-03-20
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Recalling FirmClarity Medical Systems Inc
Recall StatusTerminated
Product CodeHKI
Date Initiated2014-03-07
Date Terminated2014-08-11
Product Quantity234 lamps
Reason for Recall
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.
Firm Action
The firm, Clarity, sent a "Field Bulletin" dated March 12, 2014 to customers - risk managers and distributors by e-mail on March 12, 2014. They plan to follow this with a second letter on or about March 28, 2014 which will include a second bulletin, replacement bulbs and installation instructions. Clarity stated in the letter to its customers "In the meantime, you may continue to use your RetCAM 3."
If you have any question of concerns, please contact Clarity at +1 925 621 322 or email to: [email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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