| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00445-1 |
| Product Name/Description |
Connecter Box CB01 for Imaging Module IM910
Product code: HS-7221008
Reference number: 1023640
Serial number: 132
ARTG 150603
(Device Technologies Australia Pty Ltd - Slit lamp, ophthalmic) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
The distance between the Connector Box’s ethernet-port and internal electronic components is insufficient to provide adequate electrical insulation to the medical device in case of the presence of high voltages on ethernet installations. In its current state, the device does not conform to the relevant requirements set out in EN 60601-1:2006/A1:2013.
In cases where the device is operated while connected to an ethernet network, there is an electrical injury hazard to the user in the unlikely event that an unexpectedly high voltage is simultaneously present on the network. The risk does not exist in single fault condition.
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customer(s) are to:
1. Disconnect all connected devices from the ethernet network immediately and do not connect any devices without sufficient voltage protection.
2. Device Technologies will contact affected customer(s) to arrange the delivery of the safety kit as soon as possible. The safety kit includes a network isolator, supplement to the Instructions for Use (how to install the isolator) and a warning label to affix on the device.
3. Keep a copy of the customer letter near the device until the safety kit is installed. Once installed place the supplement to the Instructions for Use with the device. |
| Contact Information |
0401 088 409 - Jarrod Power, Product Manager |