Recall Z-0369-2019— GE Healthcare, LLC

Name: FDA recall Z-0369-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-14

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2018-09-14, terminated 2020-10-08. It names one FDA 510(k) clearance: K962738. Product: GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System. Reason: A detector can detach and fall..

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2018-09-14
Terminated: 2020-10-08
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K962738 — MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMSGE Medical Systems·cleared 1996-10-10

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 Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System

Reason for recall

A detector can detach and fall.

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