| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01113-1 |
| Product Name/Description |
Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)
Catalogue numbers: 8717733, 8717741, 10275007, 10275008, 10275009 & 10275010
ARTG numbers: 123883 & 186317 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has received reports of unintended radial motion of the detectors. This unintended motionmay cause the patient, compression related injuries. The Symbia S or T system has been designed to detect such faults and automatically shut down. If the system shuts down with the message "System requires service, please contact your customer service representative" the system will be disabled until the error is manually cleared during service There have been no reports of injury as a result of this potential motion. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Siemens local service engineer will contact customers to perform the inspection and schedule any necessary repairs to the affected systems. Siemens is advising that while waiting for the inspection to be performed, customers can continue to use their systems by adhering to the Cautions and Warnings in the user's manual and observing the patients during studies. This action has been closed-out on 08/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |