Z-1842-2020Class II

Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound...

Name: Z-1842-2020 Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound...
Creator: Philips Ultrasound Inc
Published: 2019-08-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-08-30 / Terminated / root cause: manufacturing process

FDA source

Philips Ultrasound Inc began a recall of Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging... on 2019-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1842-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-30
Posted: 2020-05-01
Terminated: 2024-11-27
Recalling firm: Philips North America LLC
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
Product code: ITX Transducer, Ultrasonic, Diagnostic
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: If you have an EPIQ, Affiniti or iE33 system, verify that all your S7-3t and S8-3t TEE transducers are programmed properly by connecting them to the system, checking the transducer temperature (TEE T) on the display, and following the instructions provided on this letter. If you determine that your transducer is not properly programmed, discontinue using the transducer immediately and contact your local Philips representative to schedule an appointment with a field service engineer. If you have an HD11 or CX50 system discontinue using the S7-3t and S8-3t transducer immediately and contact your local Philips representative for support. Please complete the included reply form on the last page and return to Philips as soon as possible via email to [email protected], or fax to 1-833-512-7756.
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1842-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1841-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01
Z-1842-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01
Z-1843-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01
Z-1844-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01

Product code ITX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)