Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1265-2014 — 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 reti

U.S. FDA — Device Enforcement · United States · 2014-03-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1265-2014
Date of alert: 2014-03-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Clarity Medical Systems Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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