Recall Z-0523-2022— GE Healthcare, LLC

Name: FDA recall Z-0523-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-04

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-11-04. It names 2 FDA 510(k) clearances: K180995, K161588. Product: GE Vscan Extend, being sold as "Vscan Extend Sector USB". Reason: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-11-04
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K180995 — Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2018-06-25
K161588 — Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC·cleared 2016-08-31

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

GE Vscan Extend, being sold as "Vscan Extend Sector USB"

Reason for recall

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

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