| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00761-1 |
| Product Name/Description |
Nordic Neuro Lab Headphones used with Siemens MRI systems
Headphones (HP)
Catalogue Numbers: HP-1.3-20169-685 to HP-1.3-2016-693
Serial Numbers: 150694 to 150701
Headphones Slim (HPS)
Catalogue Numbers: HPS-1.0-2015-001 to HPS-1.0-2016-051
Serial Numbers: 160052 to 160074
ARTG Number: 186703 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Nordic Neuro Lab has been notified that a set of the Headphone Slim (HPS) heated on the 1.5T scanner during an MRI spinal examination, causing damage to the HPS headphones. During a patient scan, the HPS headphones had become warm and hence, uncomfortable for the patient to wear. Subsequent investigation of the affected product showed clear indications of overheating. Neither the patient nor the operator were injured. However, the headphone was sufficiently heated to potentially cause injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to immediately stop using the affected headphones until further notification. Users are to use the standard auditory system from the scanner vendor (pneumatic) until resolution of the matter. Users who require high audio quality are requested to contact Siemens customer service for information on the possibility to receive a set of NNL Ear Plugs as a temporary solution until the matter is resolved.
This action has been closed out on the 25/09/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |