| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00419-1 |
| Product Name/Description |
e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)
Catalogue Numbers: 10151532, 8717733, 10275009, 10275010, 10275879, 8717741, 10275008, 10275007, 10764804, 10764803, 10764801, 10764802, 10910501, 10151531
ARTG Number: 186317 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has determined that e.cam or Symbia Systems with foresight detectors performing gated or dynamic acquisitions may lose some detector time-information. The resulting risk is that the framing of the image data and the calculated ejection fraction values may be lower. Although misdiagnosis could be possible if ejection fraction values are used as a sole input to diagnosis. In the lifetime of the product, Siemens have received three complaints, none of which led to misdiagnosis or adverse events. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software patch (Ml16-001) and corresponding operator manual addendum will be implemented. Once the software patch is installed on the affected system, the improvements will further reduce the likelihood of the issue occurring. In the interim, users are advised they may continue to use your system since the probability of occurrence is remote. To reduce the likelihood of this issue, they are advised to perform Daily Shutdown and Start-up as described in the operator manual. This action has been closed-out on 26/05/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |