| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01458-1 |
| Product Name/Description |
TomoTherapy High Performance Patient Couch
Serial Numbers: 110319, 110366, 110403, 110441, 110485
ARTG: 261300 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Emergo Australia has been made aware that under certain circumstances when using the TomoTherapy High-Performance Patient Couch, an unintended descent may be experienced when the user initiates patient couch motion in the Z-direction (up or down) for patient setup or patient unload using the keypad or PCP.
This action was undertaken prior to consultation with the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The manufacturer, Accuray, will be in contact with affected users to arrange for installation of a software update and replacement of cables within the couch subsystem.
This action has been closed out on 16/08/2018. |
| Contact Information |
(02) 9006 1662 - Emergo Australia |