| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00228-1 |
| Product Name/Description |
VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD)
Product Codes: 6802413 and 6802915
ARTG Number: 180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho is providing information regarding the potential for four wires connected to the power supply to have been misconfigured within VITROS 5600 System(s) during manufacturing. The electrical wires are located in an area that is intended to be accessed only by an Ortho-trained service representative. Normal use, maintenance and troubleshooting on VITROS 5600 System will not expose an operator to electrical hazards as a result of this issue.
If a system has the incorrect wire configuration, it is possible that if the power to an individual module is intended to be shut off, it will remain on. However, there is no risk to Ortho-trained service personnel if they follow normal procedures and power off the appropriate module or the VITROS 5600 System as a whole prior to working on a component. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that there is no impact to the results generated with an affected system. An Ortho representative will be inspecting the wiring of all affected systems and will reconfigure the wiring where required. This action has been closed-out on 09/05/2017. |
| Contact Information |
1800 032 359 - Ortho Clinical Customer Technical Services |