| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01207-1 |
| Product Name/Description |
Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)
Multiple item numbers and serial numbers
ARTG Numbers: 119074, 133015 & 133014 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has become aware that specified TCM4 series Base Units do not comply with the Medical Safety Standard IEC 60601-1, 2nd edition, subclause 15(b).
The implication is that there is a potential risk of receiving an electric shock under certain conditions as follows:
The monitor is connected to the mains outlet and the mains switch is ON; The battery is fully charged (or no battery is present); The operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor to OFF; The operator touches the two metal pins on the mains plug or on the monitor's line cord receptacle after disconnecting the line cord. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is informing users of the issue and is providing fluorescent warning stickers to be placed on the device and work around instructions to mitigate the risk if the device must be used. A hardware correction is forthcoming to permanently correct the problem. |
| Contact Information |
1800 247 254 - Simon Eldred |