| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00305-1 |
| Product Name/Description |
SonoSitePowerPark Dock and Stand Module(s) used with SonoSite Ultrasound Systems
1) PowerPark Stand and DockModule(s) used in conjunction with the X-Porte Ultrasound System
2) PowerPark Stand Module(s)
Part Numbers: P12822-25, P12822-26, P13740-01, P13871-10, P13871-11 andP13736-01
Manufactured from July 2012 through December 2014
ARTG Number: TBA |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
PowerPark consists of two components: theStand Module (attaches to the underside of the SonoSite stand) and the Dock Module (plugs into a power outlet and sits on the floor).
1) When used in conjunction with X-Porte ultrasound system stand, damage to the PowerPark modules can occur by a docking approach from extreme angles or from excessive movement of the stand when docked. If the PowerPark experiences too much connector damage (i.e. blackened pins) it could be
rendered inoperable and it will stop charging the system.This issue affects both the Stand Module and Dock Module .
2) During the manufacturing process of the Stand Module, an incorrect component was used. This component leaves the affected Stand Module out of specification. Stand Modules manufactured with this incorrect component will need to be returned to SonoSite for serviced at the expense of SonoSite. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To resolve these issues, it is necessary to perform a replacement of the affected PowerPark as follows:
1) SonoSite requires that customers to return the Stand Module with the X-Porte stand. Additionally, the PRIMARY Dock Module that has been utilised with the X-Porte stand will need to be returned and replaced.
2) Stand Modules manufactured with the incorrect component will need to be returned to SonoSite for serviced at the expense of SonoSite. Stand Modules will be inspected, serviced to be within specification, and returned. This action has been closed-out on 29/08/2016. |
| Contact Information |
1300 663 516 - FUJIFILM SonoSite |