CEREC AC with CEREC Ominicam (2018-05-15)
- Starting date:
- May 15, 2018
- Posting date:
- May 25, 2018
- 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-66856
Affected products
CEREC AC with CEREC Ominicam
Reason
A new warning was added in the instruction for use of the CEREC AC/AF/AI with Ominicam. The device might be dangerous for people with epilepsy. The pulsating light which is used from the Omnicam system for image acquisition, in rare cases might trigger epileptic seizure.
Affected products
CEREC AC with CEREC Ominicam
Lot or serial number
All serial numbers.
Model or catalog number
6371830
Companies
- Manufacturer
-
Sirona Dental Systems GMBH
Fabrikstrasse 31
Bensheim
64625
GERMANY