Philips Ultrasound Inc recalls Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagn…

Recall date

August 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1844-2020

FDA classification

Class II

Brand / firm

Philips Ultrasound Inc

Sold / distributed

Worldwide distribution - US Nationwide distribution.

Why it was recalled

The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies