| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01031-1 |
| Product Name/Description |
Rigid Arm Supports
(used as part of Posiboard-2 and Positrest)
Reference Numbers: 106047, 106015
Lot Numbers: M164340, M178170, M165430, M165440, M191710 and M192470
ARTG Number: 149575 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Civco Radiotherapy have identified that specific units of Rigid Arm Supports may have a height difference of approximately 17mm compared to those manufactured after July 2012.
Due to the potential height variation in the Rigid Arm Supports there is potential for mistreatment if there are multiple devices in the facility with varying heights between simulation and treatment. Changes in arm position due to variation will impact the position of the chest wall and breast position. A 16.8mm variation in arm positioner could result in chest/breast/heart position changes which exceed expected treatment planning margins. |
| Recall Action |
Recall |
| Recall Action Instructions |
alphaXRT is requesting Customers:
1. If your facility has an affected device and a newer device which is not included in the list, then usage should be immediately suspended;
2. Complete the supplied customer acknowledgment form and return it to NP@alphaXRT.com;
3. Retain a copy of the Customer Letter along with your most current product labelling;
4. Ensure relevant staff members are informed of this recall including relevant clinicians who may need to monitor for adverse events.
5. Place the notification letter in a prominent position for at least one month.
This action has been closed out on the 25/09/2018. |
| Contact Information |
02 9552 4090 - alphaXRT |