| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01650-1 |
| Product Name/Description |
Biograph mCT and Biograph mCT Flow
Catalogue/Lot Numbers: 10248668, 10248669, 10248670, 10248671, 10248672, 10248673, 10250743, 10250745, 10507786, 10528955, 10529159
ARTG Number: 144218 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified that the light marker windows used for the positioning laser and integrated into the front cover of the Biograph mCT or Biograph mCT Flow system may loosen and potentially drop out. In this case, there is a risk that a person could touch the electrical or rotating parts of the gantry in the unlikely event that they reach through the window opening. This could result in a serious injury such as electrical shock or physical harm. There have not been any reports of complaints regarding this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to conduct a visual inspection of their Biograph mCT or Biograph mCT Flow and that in the event that the light market window is missing or loose, they should not use the Biograph mCT or Biograph mCT Flow and should immediately contact their local Siemens Customer Service Engineer for correction of the problem.
This action has been closed out on 24/07/2019 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |