—#179640

Product

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

FDA product code: ITX — Transducer, Ultrasonic, Diagnostic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K172607
Affected lot / code info: All lots.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips Ultrasound Inc
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution.

Timeline

Recall initiated: 2019-08-30
Terminated: 2024-11-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179640. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.