| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00330-1 |
| Product Name/Description |
Hyperparallel Optical Coherence Tomograph
Product Code: HP-OCT
Serial Numbers: 14329, 15237
ARTG 352022
(Cylite Pty Ltd - Spectral-domain optical coherence tomography system) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
26/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
During recent internal testing, Cylite identified a software problem that could potentially result in the measurement of the calibration target being inaccurate by a small amount (up to 0.2D). This could cause a calibration check to fail even if the instrument is still well-calibrated, which may result with the end user ceasing use of the instrument when this is not warranted.
Cylite has verified that this problem does not impact the precision or accuracy of measurements of human eyes (clinical safety and performance of HP-OCT) and only affects measurements of the calibration target.
There have been no patient injuries or complaints reported to Cylite to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
- Continue conducting the calibration check process as per the User Manual’s instruction (at least every 3 months) and continue to use the device if the calibration check shows a pass.
- If the Focus software indicates a failed calibration on two (2) consecutive attempts, stop using the instrument.
- Once received the new calibration Check Target, update Focus software to the latest revision v1.5.16 to continue the use of the instrument and return the original calibration check target on hand by using the reply-paid envelope provided.
This action has been closed out on 12/06/2024 |
| Contact Information |
03 9581 2601 - niki.liu@cyliteoptics.com - Niki Liu - Regulatory Associate |