| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00138-1 |
| Product Name/Description |
Spot Vision Screener 100 with software version up to and including 3.0.01.07
Model Number: Model VS100
ARTG Number: 293205
(Welch Allyn Australia - Visual function analyser) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
If the device is not used or charged every five months, the coin cell battery that maintains the system clock may become depleted. Once the coin cell battery has depleted, the system clock will reset to a date in the past (date of the last installed software release for example). This may cause the patient age to be calculated incorrectly. Please note, the patient age is used by the Spot Vision Screener 100 to determine referral criteria for certain screening conditions–specifically Anisometropia, Myopia, Astigmatism and Hyperopia. An incorrect patient age could result in an incorrect (either under or over) referral recommendation. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Welch Allyn is recommending users review new software releases and determine if the device should be updated. Software updates can be downloaded at www.welchallyn.com.au. In the interim, users are advised to refer to the additional instructions to re set the system clock if the issue occurs.
This action has been closed out on the 27/11/2018. |
| Contact Information |
1800 650 083 - Customer Service Support |