Recall Z-1404-2013 ยท HKO Refractometer, Ophthalmic
Canon Inc.
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.
| Date | May 25, 2013 (initiated Dec 5, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Canon initiated recall by sending letters on November 22, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken and contact information. |
| Quantity | 384 units |
| Distribution | Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.