Transducer S7-3t UDI — Class II medical device recall Z-1841-2020
Terminated recall by Philips Ultrasound Inc, reported 2020-05-13, distributed nationwide. The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly
| Recall number | Z-1841-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound Inc, Bothell, WA, United States |
| Recall initiated | 2019-08-30 |
| Classified | 2020-05-01 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2024-11-27 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884838061439 |
| Model numbers | 989605406772 |
Product
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1841-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.