3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2

FDA device recall Z-2517-2023 · posted 2023-09-06 · Completed

Recall details

Recalling firm

Philips Ultrasound, Inc.

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.

Action taken

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 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

Status

Completed

Product code

ITX

Quantity affected

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

Date initiated

2023-06-30

Date posted

2023-09-06

Location

Bothell, WA

Related 510(k) clearances