Specular Microscope (2019-02-12)
- Starting date:
- February 12, 2019
- Posting date:
- March 8, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69234
Affected Products
Specular Microscope
Reason
The Specular Microscope CEM-530 does not meet the EMC standards. It has exceeded the upper limit of the electromagnetic compatibility standard (EMC: IEC 60601-1-2) while at the same time, medical device is required not to erroneously operate from external electromagnetic noise under EMC standard.
Affected products
Specular Microscope
Lot or serial number
- S/N. 120080 to S/N. 120099
- S/N. 141145 to SN. 141548
- S/N. 150363 to S/N. 150539
- S/N. 160342 to S/N. 160426
- S/N. 170001 to S/N. 170021
Model or catalog number
CEM-530
Companies
- Manufacturer
-
Nidek Co., Ltd.
34-14 Maehama, Hiroishi-cho
Gamagori, Aichi-Ken
443-0038
JAPAN