Recall Z-0128-2021— GE Healthcare, LLC

Name: FDA recall Z-0128-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-08

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-09-08, terminated 2021-04-28. It names 2 FDA 510(k) clearances: K163331, K091536. Product: System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.. Reason: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-09-08
Terminated: 2021-04-28
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K163331 — Discovery MR750 3.0T +4 moreGe Medical Systems, LLC·cleared 2017-03-17
K091536 — OPTIMA MR450WGe Medical Systems, LLC·cleared 2009-07-17

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

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

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