Drug recall
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be…
FDA recall event 65082 · Class II · Canon Inc.
Key facts
| Event ID | 65082 |
|---|---|
| Recall numbers | Z-1404-2013 |
| Recalling firm | Canon Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2 s refractive power (SPH value) sometimes indicated abnormal value… |
| Initiation date | Dec 5, 2012 |
| Report date | Jun 5, 2013 |
| Termination date | Sep 20, 2013 |
| City | Tokyo |
| Country | Japan |
| FEI number | 1000181430 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: