| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01032-1 |
| Product Name/Description |
Janus and Janus G3 Automated Workstation
Product Numbers: AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001
ARTG Number: 210712 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
10/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
PerkinElmer have become aware that Janus and Janus G3 Automated Workstations were failing production final acceptance testing due to a ‘Horizontal Motion Error’ message displayed on the system. Further investigation concluded that two printed circuit boards (PCB) used in MDT models of Janus and Janus G3 were manufactured with the incorrect resistor values. This anomaly affects component part number 7101640 (PCB-Quad Motor Controller MDT) and part number 7101647 (PCB-Quad Motor Controller Gripper). This anomaly could result in the ‘Horizontal Motion Error’ being displayed and result in instrument down time.
The affected printed circuit boards control functional movement of the instrument head and gripper. Impact to any user samples is low, as the instrument clearly displays an error message, ‘Horizontal Motion Error’.
PerkinElmer field service personnel have been instructed to schedule a customer service visit to upgrade affected customer systems with revised printed circuit boards. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
PerkinElmer is requesting customers:
1. Be aware that there is potential for the ‘Horizontal Motion Error’ message to display which could result in instrument down time;
2. Follow guidance provided in the Janus Automated Workstation User Manual when the ‘Horizontal Motion Error’ message displays; and
3. If you have additional questions, contact PerkinElmer Technical Support for further assistance.
This action has been closed out on the 14/09/2018. |
| Contact Information |
1800 033 391 - PerkinElmer Technical Support |