Recall Z-0543-2021— GE Healthcare, LLC

Name: FDA recall Z-0543-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-27

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-10-27, terminated 2024-05-03. It names one FDA 510(k) clearance: K173830. Product: MAC VU360, Electrocardiograph. Reason: Incorrect patient identification and/or patient demographic errors..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-10-27
Terminated: 2024-05-03
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K173830 — MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.·cleared 2018-09-18

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

MAC VU360, Electrocardiograph

Reason for recall

Incorrect patient identification and/or patient demographic errors.

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