FDA Device recall 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 refracti…
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refracti… by Canon, citing 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 indica….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1404-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-05 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Canon |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Number 6937B002AA. All serial numbers from the first unit onward. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1404-2013%22
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