FDA Device recall Z-1842-2020

Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic…

FDA Device
Class II
terminated
Published 2020-05-13

On 2020-05-13 the FDA classified a Class II recall of Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic… by Philips Ultrasound, citing 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 t….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1842-2020
Classification	Class II
Status	terminated
Initiated	2019-08-30
Published	2020-05-13
Last updated	2026-09-13 11:55 UTC
Company	Philips Ultrasound
Distribution	US

Product

Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies

Reason

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

Identifiers

code_info	All lots.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1842-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.