FDAFDA · Food and drugs·Recall number Z-1404-2013
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Published June 5, 2013 · Recall initiated: December 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Canon Inc.
- Distributor
- Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
- Lot
- Catalog Number 6937B002AA. All serial numbers from the first unit onward.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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