Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Philips Medizin Systeme Böblingen GmbH IntelliVue Multi-Measurement Module X3 [Product Number: 867030] [HKMD number: 200344].
According to the MHRA, the manufacturer has identified that the IntelliVue Multi-Measurement Module X3 with Option C99 has a “hemo” specific profile, which is used when IntelliVue X3 is connected to Philips Hemodynamic Application. One of the settings in “hemo” profile is the calibration setting of Invasive Blood Pressure.
This calibration setting has been inadvertently switched to “OFF” in the “hemo” profile with software version P.0, preventing the user of the Philips Interventional Hemodynamic Application to be able to change the calibration factor of the reusable Invasive Blood Pressure transducer, or to initiate a calibration procedure.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/alU2R8QJSS5REBy0
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 25 Jun 2024
Updated on 26 Jun 2024