| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00076-1 |
| Product Name/Description |
SIM System with SIM dock power supply model Franmar FRA012-S05-I
ARTG Number: 227029 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Simavita has recently received notification from their third party supplier that the plug adaptor, which is provided together with the SIM dock power supply, has a design fault.
Under some circumstances, one of the pins from the plug adaptor may detach during removal from the power point and remain protruding from the power point creating an electrocution hazard. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised to:-
1. Identify the location of the SIM dock power supplies at their facility;
2. DO NOT unplug any of these power supplies that are currently plugged into a power point. The risk of electrocution only occurs where the pin has become detached from the plug adaptor & remains in the power point.
3. Immediately notify internal maintenance personnel in order to carry out safe removal of the power supplies from each outlet. Following safe removal all units must be quarantined until the product correction has been carried out;
4. Where one of these power supplies is not currently plugged into a power point, DO NOT plug in & use that power supply & quarantine the units as per internal procedures;
5.Immediately inspect any power points for the above fault in locations where it is known this device is regularly used & notify appropriate internal personnel in the event this anomaly is identified; and
6. Share this Notification internally to all appropriate staff. This action has been closed-out on 18/07/2016. |
| Contact Information |
1300 746 736 - Simavita Customer Service |