| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00855-1 |
| Product Name/Description |
E.CAM or Symbia E System: Rear Casters of the Collimator Cart
Catalogue numbers: Collimator Carts 7760908, 7760882
ARTG number: 186317 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
The rear casters of the collimator cart may become loose and under certain circumstances result in the cart tipping towards the operator. This problem occurs when two conditions are present: 1. The caster has insufficient clamping force and 2. The affected caster passes over a low spot in the floor. If both conditions exist, it is possible the caster will dislodge from the bottom of the cart, allowing the cart to tip backwards toward the operator. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised that they can continue to use your system while waiting for the field correction to be scheduled and performed. However, if you suspect a caster is loose, as indicated by shaking while the cart is in motion, discontinue use of the collimator cart and notify your local Service representative.
A retention bracket will be installed on all affected devices to correct the problem. This action has been closed-out on 24/05/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |