Use cautionMedical device recall · FDA · Published August 30, 2019
Philips Transducer S8-3t: Temperature Measurement Risk in TEE Ultrasound
Philips recalls S8-3t transducers for potential patient injury due to incorrect temperature measurement during transesophageal echocardiography (TEE) scans.
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
“Philips Transducer S8-3t: Temperature Measurement Risk in TEE Ultrasound.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67082-philips-transducer-s8-3t-temperature-measurement-risk-in-tee-ultrasound. Based on FDA recall #Z-1843-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1843-2020%22&limit=1).
The FDA announced on 2019-08-30 that Philips Ultrasound Inc is recalling Transducer S8-3t devices because they may fail to measure temperature correctly, posing a risk of patient injury. The agency stated the recall addresses transducers not properly programmed during manufacturing.
According to the FDA, some Transesophageal (TEE) transducers were not properly programmed during manufacturing, causing the system to be unable to correctly measure the temperature on the distal tip. This issue may result in affected transducers not initiating auto-cool during use, which could result in patient injury.
Context
GovInfoNow's records show Philips Ultrasound, Inc has had 14 other recalls since 2019-04-29. Recent similar recalls include the Philips L12-5 Ultrasound Transducer Recall on 2025-09-05 and the Philips SCNHD LA L7-... Transducer Probe Recall on 2025-07-03, both addressing useful life labeling. Other recent recalls of similar products include the Philips Cardiac Workstation 7000 recall (2026-07-01), the Covidien Mon-a-Therm Temperature Probe Recall (2026-04-23), and the Philips EPIQ Elite Ultrasound System Recall (2026-08-07).
How to tell if you have this one
Check for the UDI (01)00884838073524 or REF 989605431171 on the transducer. These transducers work with Philips EPIQ 7, Affiniti 70, EPIQ 5, and EPIQ CVxi ultrasound systems.
Brand
Philips
Product
Philips Ultrasound Inc recalls Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution.
Recall number
Product, codes & lots
Z-1841-2020
Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies; All lots.
Z-1842-2020
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; All lots.
Z-1843-2020
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; All lots.
Z-1844-2020
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; All lots.
Based on the official FDA remedy
What to do — step by step
Check Transducer Details
Look for the UDI (01)00884838073524 or REF 989605431171 on the transducer.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1843-2020 (August 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1843-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.