Recall Z-2306-2021— Philips Ultrasound Inc

Name: FDA recall Z-2306-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-22

Class II · Completed

Class II FDA medical device recall by Philips Ultrasound Inc, initiated 2021-07-22. It names one FDA 510(k) clearance: K182857. Product: EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi. Reason: Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury..

Recalling firm: Philips Ultrasound Inc
Classification: Class II
Status: Completed
Initiated: 2021-07-22
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K182857 — EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.·cleared 2018-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi

Reason for recall

Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.