Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-00805-1 |
Product Name/Description |
ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An in vitro diagnostic medical device (IVD)
Battery modules: below 910-311P0009Nxxx
All serial numbers affected
ARTG Number: 228382 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
27/08/2015 |
Responsible Entity |
|
Reason/Issue |
Radiometer has recently become aware of a potential issue where a battery module had overheated caused by the continued charging of a collapsed battery cell. They have identified that worn battery modules with limited or no capacity manufactured in production runs below 910-311P0009Nxxx are prone to cell collapses. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Radiometer is advising users that battery modules below 910-311P0009Nxxx will be replaced with a newly designed battery module. Radiometer is advising users with battery modules 910-311P0009Nxxx and above will be required to undertake 12 monthly checks of the capacity of the battery modules. This action has been closed-out on 11/08/2016. |
Contact Information |
1800 247 254 - Radiometer Pacific |