ORTHOPANTOMOGRAPH OP 3D (2017-12-05)

Starting date:

December 5, 2017

Posting date:

January 8, 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-65534

• 
  Reason
• 
  Affected products

Affected Products

ORTHOPANTOMOGRAPH OP 3D

Reason

The KaVo ORTHOPANTOMOGRAPH OP 3D Panoramic X-Ray Unit (Serial #: kt1700214) was erroneously distributed with an incorrect user manual and DVD. The user manual D519207 REV. 5 is missing a warning statement "the device must not be used for screening examinations."

Affected products