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 Medical Systems Nederland B.V. Philips Ingenia Evolution systems with software R5.7.1 [Ingenia systems: Ingenia 1.5T and Ingenia 3.0T] [HKMD number: 120210, 110501].
According to the MHRA, the manufacturer has identified a software issue affecting Philips Ingenia systems with Evolution upgrade and running R5.7 software. If the operator manually adjusts the setting for patient ventilation down from the default setting of Level 3, the Operator Console Display (OCD) does not present a Patient Ventilation Warning after the operator starts the scan. However, when the operator adjusts the ventilation setting using the Vital Screen in the exam room, warning symbols appear on the Vital Screen. Additionally, if the operator adjusts the ventilation setting using the Patient Ventilation Control in the OCD system menu, the recommended level is shown on the OCD system menu.
If patient ventilation remains below setting 3, patient may experience an increase of body temperature or burning sensation.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/OLq7w0lbSDFbDT1Y
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 May 2024