CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report

Transducer S8-3t recalled by Philips Ultrasound

Philips Ultrasound is recalling Transducer S8-3t, distributed nationwide in the US. The recall was initiated on 30 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots.

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1844-2020
FDA event ID: 84902
Recalling firm: Philips Ultrasound, Bothell, WA
Classification: Class II
Status: Terminated
Recall initiated: 30 Aug 2019
FDA classified: 1 May 2020
Reported: 13 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Imaging Equipment

Timeline

30 Aug 2019	Recall initiated by company
1 May 2020	Classified by FDA	+245 days
13 May 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots.

Where was it sold?

Worldwide distribution - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 84902

This product is part of a recall event; the main page for the event is Transducer S8-3t recalled by Philips Ultrasound.

Reported	Class	Recall	Company	Reason	Where
13 May 2020	CLASS II	Transducer S8-3t recalled by Philips Ultrasound	Philips Ultrasound	Temperature Abuse	Nationwide
13 May 2020	CLASS II	Transducer S7-3t recalled by Philips Ultrasound	Philips Ultrasound	Temperature Abuse	Nationwide
13 May 2020	CLASS II	Transducer S7-3t recalled by Philips Ultrasound	Philips Ultrasound	Temperature Abuse	Nationwide

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