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Health Canada Medical devices

Ultrasound System 5500 and 5500CV

Issued April 9, 2024
Issue
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). Recall Start date: March 27, 2024
Hazard description
Performance
Product
Product name
Ultrasound System 5500 and 5500CV
Reference
ID
RA-75366