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

• 
  Reason
• 
  Affected products

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