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Completed

3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000

FDA Recall Z-2517-2023 · Posted 2023-09-06

Recalling FirmPhilips Ultrasound, Inc.
Recall StatusCompleted
Product CodeITX
Date Initiated2023-06-30
Product Quantity449

Reason for Recall

Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.

Firm Action

On 6/30/23, recall notices were sent to customers who were advised to do the following: 1) Stop usage and/or distribution of affected transducers and secure them in a location where they cannot inadvertently be used. 2) Circulate the notice to all users of this device so that they are aware of the issue. Retain this notice with your system(s) and ensure the letter is in a place likely to be seen/viewed. 3) Complete and return the response form via email to: [email protected] Field Service Engineers will visit your site to provide a replacement device, and collect the affected product. Contact Customer Care Solutions Center if you need further information or support concerning this issue at 1-800-722-9377. On 7/24/23 additional recall notices were distributed to customers informing them that additional devices were found to be affected.

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of FL, MN, AZ, NC, CA, MO, OH, WV, AL, NH, IN, IL, VT, PA, NY, NE, TX, WI, MI, KY, NV, MA, SD, LA, CO, TN, AK, GA, WA, UT, NM, ME, AR, SC and the countries of Italy, China, Netherlands, New Zealand, Hungary, Australia, France, Thailand, C¿te D'Ivoire, Germany, Canada, Mexico, Spain, Saudi Arabia, Uzbekistan, Greece, Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)Philips Ultrasound, LLC · 2022-09-27K132304EPIQ DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc. · 2013-08-21K120321CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Health Care · 2012-02-17K081661HD15 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc. · 2008-06-24K043535HD11 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc. · 2005-01-06K042540PHILIPS IU22 ULTRASOUND SYSTEMPhilips Ultrasound, Inc. · 2004-10-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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