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Full Auto Ref-Keratometer
- Starting date:
- January 17, 2013
- Posting date:
- February 4, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-17221
Recalled Products
- Full Auto Ref-Keratometer
Reason
Potential variations in values measured in the Ref mode (Refractive Power) were reported with respect to the firmware included in RK-F2 Full Auto Ref-Keratometer. Canon Inc. has determined that there are potential variations in the optical system switching time between the Alignment Motor and Measurement Period and, therefore, fluctuations in measurement values may occur. Canon Inc. will resolve this potential issue by upgrading the firmware in the RK-F2 Auto Ref-Keratometer.
Affected products
A. Full Auto Ref-Keratometer
Lot or serial number
- 200004
- 200005
- 200011
Model or catalog number
RK-F2
Companies
- Manufacturer
- Canon Inc.