Philips Ultrasound Inc: Medical Device Recall in 2020 - (Recall #: Z-1843-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies

Product Classification:

Class II

Date Initiated: August 30, 2019

Date Posted: May 13, 2020

Recall Number: Z-1843-2020

Event ID: 84902

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

Status: Terminated

Product Quantity: N/A

Code Information:

All lots.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated