Recall Z-1404-2013— Canon Inc.
Class II · Terminated
Class II FDA medical device recall by Canon Inc., initiated 2012-12-05, terminated 2013-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Canon Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-05
- Terminated
- 2013-09-20
- Firm location
- Tokyo, N/A, Japan
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.