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