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
This recall has been terminated (originally issued August 30, 2019).
- Company
- Philips Ultrasound, Inc.
- Recall Initiated
- August 30, 2019
- Terminated
- November 27, 2024
- Recall Number
- Z-1841-2020
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide distribution - US Nationwide distribution.
Lot / Code Info
All lots.
Root Cause
Process control
Action Taken
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 ultrasound.corrections@philips.com, or fax to 1-833-512-7756.