Health product recall

Pentacam Axl (2017-11-27)

Starting date:
November 27, 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, Hospitals, Healthcare Professionals
Identification number:
RA-65522

Affected Products

PENTACAM AXL

Reason

Possibility of displaying the erroneous output when a specific workflow sequence for performing the power calculation is utilized. The colored display of the Quality Specifications (QS) value changes from yellow to white, while the output values remained the same.

Affected products

PENTACAM AXL

Lot or serial number

1.21r01

1.21r03

1.21r11

1.21r13

Model or catalog number

70100

 

Companies
Manufacturer

OCULUS Optikgeraete GmbH

Muenchholzhaeuser
Strasse 29

Wetzlar

35582

GERMANY