Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to m
FDA device recall Z-1404-2013 · posted 2013-05-25 · Terminated
Recall details
- Recalling firm
- Canon Inc.
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HKO
- Quantity affected
- 384 units
- Distribution
- Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
- Date initiated
- 2012-12-05
- Date posted
- 2013-05-25
- Date terminated
- 2013-09-20
- Location
- Ohta-ku, Tokyo, Japan
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