| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01424-1 |
| Product Name/Description |
Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13
Serial Numbers: 0031 7130, 2721 6111, 3821 7110
ARTG Number: 175820 (Designs for Vision Aust Pty Ltd - Corneal topography system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, OCULUS Optikgeräte, has identified recently that when a specific workflow sequence for performing the power calculation is utilised, the coloured display of the quality specification (QS) value changes from yellow to white, while the output values remained the same. The result is that the interpretation of the data, by solely considering the QS value, changes from “Check the measurement results; repeating the measurement by having any doubts” (yellow flagged) to “the measurement is OK” (white flagged). Although the device has a secondary warning
(plausibility check) whereby the software flags any axial length difference greater than 0.3mm, indicating with a warning and displaying the suspicious difference of the axial length, the company has determined that in rare cases, this workflow sequence could result, in displaying an erroneous output.
There have been no injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Paragon Care is providing users with a software upgrade as a permanent correction.
This action has been closed out on 30/08/2019 |
| Contact Information |
1300 369 559 - Paragon Care |