| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00657-1 |
| Product Name/Description |
Siemens e.cam Systems
(Nuclear medicine gamma camera)
Multiple catalogue numbers installed prior to December 31st 2004 affected
Part numbers: 4380213, 4380221, 5242826, 5977066, 5989079, 5991109, 5992099, 7324143, 7823946, 7823953.
ARTG number: 186317 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has received a report of unintended detector motion. The cause of this motion was determined to be the simultaneous failure of two components, the radial brake circuit and touch pad. This unique combination of failures caused the axis brake to be ineffective, which ultimately led to the detector motion.
Additionally, activating the emergency stop (e-stop) or a system power failure, between 0.05 and 0.1 seconds after initiating motion could lead to this failure. Siemens has determined that the likelihood that these events would occur over such a small time window is extremely rare. The most likely condition that could lead to a rapid power cycling is a touch pad failure. There have been no reports of injury as a result of this issue; however, it is remotely possible that a compression injury to the patient could occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
-PRODUCT CORRECTION
Siemens has designed and will install an improved brake control circuit which
will correct this condition. Users are advised that the e-stop should still be used confidently and they can continue to use their system with confidence while waiting for the repair to be scheduled and performed. Users are reminded that daily touch test and/or its failure should not be ignored. If they experience difficulty or a failure while performing the daily touch pad test, discontinue use and contact their local service representative. This action has been closed-out on 05/09/2016. |
| Contact Information |
1800 310 300 - Technical Support Centre |