Health product recall

Ultrasound System 5500 and 5500CV

Last updated

Summary

Product
Ultrasound System 5500 and 5500CV
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Ultrasound System 5500 Not applicable. 795143 795145
Ultrasound System 5500CV Not applicable. 795141

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Ultrasound Llc

22100 Bothell Everett Highway, Bothell, Washington, United States, 98021-8431

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75366

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