Recall Z-0919-2022— GE Healthcare, LLC

Name: FDA recall Z-0919-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-16

Class II · Completed

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-03-16. It names one FDA 510(k) clearance: K152993. Product: MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008. Reason: Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Completed
Initiated: 2022-03-16
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K152993 — MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc.·cleared 2016-01-12

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

MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

Reason for recall

Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

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