Health Canada posted a medical device safety alert concerning BodyGuard 323 Infusion Pump [Serial number: 69370, 71309, 71329, 71462], manufactured by Caesarea Medical Electronics Ltd.
The manufacturer has identified a software issue with the BodyGuard 323 that results in an over-infusion of medication without alarm. For the over-infusion to occur, specific set-up conditions must exist at the same time. Serious injuries and/or deaths could occur due to the failure mode associated with this recall.
For details, please refer to the following Health Canada website:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/43737r-eng.php
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 February 2015