Recall Z-2517-2023 ยท ITX Transducer, Ultrasonic, Diagnostic
Philips Ultrasound, Inc.
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
| Date | Sep 6, 2023 (initiated Jun 30, 2023) |
| Status | Completed |
| Reason | 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. |
| Root cause | Process control |
| 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: ultrasound.corrections@philips.com Field Service Engineers will visit your site to provide a replacement device, and collect the affecte |
| Quantity | 449 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042540 | PHILIPS IU22 ULTRASOUND SYSTEM Philips Ultrasound, Inc., Oct 4, 2004 |
| K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Jan 6, 2005 |
| K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Jun 24, 2008 |
| K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM Philips Health Care, Feb 17, 2012 |
| K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Aug 21, 2013 |
| K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ul Philips Ultrasound, LLC, Sep 27, 2022 |