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.
Health Canada has posted a medical device safety alert concerning Philips Ultrasound LLC Ultrasound System 5500 and 5500CV [Model or catalog number: 795143, 795145, 795141] [HKMD Number: 230329].
According to the Health Canada, if, during a procedure where multiple transducers are connected to the compact 5000, one of which is a transesophageal echocardiography (TEE) transducer and imaging is being performed with one of the other transducers, the TEE transducer may continue to receive power, which may cause the transducer head to exceed the established temperature limit (43°c/109.4°f). The fault condition is triggered by the vibrations caused by disconnecting and connecting/reconnecting of the transducer(s).
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/ultrasound-system-5500-and-5500cv
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 10 Apr 2024
Updated on 11 Apr 2024