| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00065-1 |
| Product Name/Description |
Panther and Panther Fusion Systems with 19-in monitor
Product code: 902615
Serial Nos: 2090002307 to 2090002532
Manufactured between April 2017 and Nov 2017
ARTG Number: 260039 (Gen-Probe Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Hologic has been made aware that the touch screen monitor provided with certain Panther and Panther Fusion Systems has the potential for the glass panel to separate due to inadequate adhesion between the glass panel and the monitor.
Hologic has received 2 complaints where the glass panel separated from the Panther monitor. To date, there have been no reports of injuries associated with this defect; however there is a potential risk that the glass panel may fall and injure an operator. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Hologic will contact affected customers to arrange for an interim solution to secure the glass panel to be installed. Subsequently, a replacement monitor with this issue corrected will be installed once made available.
This action has been closed out on 19/09/2018 |
| Contact Information |
1800 264 073 - Hologic Technical Centre |