FDA Device recall 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 - P…
- 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)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - P… 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-1841-2020 |
| 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)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
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-1841-2020%22
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