Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its RF 3000 device [UPN:6221 (M001262210); Serial number: 11414007 ,11414008 , 11414009 ,11414010 , 11414012 , 11414013 ,11414019, 11414020, 11414021 ,11414022, 11414023 , 11414024 ,11414026, 11414027, 1414028, 11414029, 11414030, 81213006, 81213007, 121313001, 121313002 ,121313004, 121313005 ,121313006 , 121313008 ,121313010 ,121313011, 121313013 , 121313014,121313015 , 121313016, 121313017, 121313019 , 121313020, 121313021, 121313022].
The manufacturer has identified that RF 3000 fuse information on the label is incomplete with 'L' missing which stands for 'low capacity break'. The fuse information on the label is '220-240V~ 250V, T3.15A', while it should be '220-240V~ 250V, T3.15AL'. The fuse information in the DFU is '220-240V~: T3, 15AL 250V, 5x20 mm' is correct.
According to the manufacturer, the field action is only related to the Chinese label over-labeling process. No other products or countries are affected by this action. There have been no complaints or adverse events reported to the manufacturer for this labeling discrepancy
The affected customers will be contacted to arrange an onsite service to over label the Chinese label on their RF 3000.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 06 February, 2018