Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00097-1
Product Name/Description	IntelliSpace Critical Care & Anaesthesia Information Systems Affected Models: 865047 IntelliVue Clinical Information Portfolio (ICIP), Rev D 865209 IntelliVue Clinical Information Portfolio (ICIP), Rev E 866072 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. F 866148 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. G ARTG Number: 98511
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	3/02/2015
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	A software configuration defect has been identified that impacts one Standard Content (configuration that is shipped with the product) unit of measure (gm/m2) for the Body Surface Area (BSA). The defect involves an incorrect multiplier in the configuration that causes an incorrect calculation of medication dosage. If the user does not identify that an incorrect multiplier exists in the Standard Content, a patient may receive a dose of medication that is incorrect (10 times the intended dosage).
Recall Action	Recall for Product Correction
Recall Action Instructions	Users are advised to implement the instructions in the customer letter if the BSA (gm/m2) Standard Content is used in their systems configuration. Philips has initiated a software correction to address this issue. A Philips representative will contact customers to schedule the implementation of this correction. This action has been closed-out on 20/07/2016.
Contact Information	1800 251 400 - Philips Customer Care Centre