Recall Z-0595-2022— GE Healthcare, LLC

Name: FDA recall Z-0595-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-23

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-12-23. It names 2 FDA 510(k) clearances: K163619, K142098. Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.. Reason: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-12-23
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K163619 — SIGNA PET/MRGe Medical Systems, LLC·cleared 2017-02-14
K142098 — SIGNA PET/MRGe Medical Systems, LLC·cleared 2014-11-24

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 MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.

Reason for recall

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

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