Canon RK-F2 Ref-Keratometer Recalled for Abnormal Refractive Power Readings
Canon Inc. is recalling 384 RK-F2 Ref-Keratometers because the device may display abnormal refractive power values in approximately 5% of cases.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Canon Inc. is recalling 384 units of the Full Auto Ref-Keratometer RK-F2 (Catalog Number 6937B002AA). This medical device is intended to measure the refractive power and the radius of corneal curvature of the human eye. The recall covers all serial numbers from the first unit onward.
The recall was initiated after Canon Inc. received 17 claims from foreign sales companies between October and November 2012. These reports indicated that the measurement value of the device's refractive power (SPH value) sometimes displayed an abnormal value, an issue that occurs with approximately 5% probability.
The affected units were distributed worldwide, including the United States, Australia, Japan, Korea, Singapore, and the United Kingdom. Consumers and healthcare providers should stop using the device and contact Canon Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- Canon Inc.
- Hazard
- Affected units
- 384
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number 6937B002AA. All serial numbers from the first unit onward.
Distribution
Distributed nationwide across the United States.
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