Recall Z-0598-2022— GE Healthcare, LLC

Name: FDA recall Z-0598-2022
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. FDA's recall record names no specific 510(k) clearance for this event. Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, 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

Product description

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, 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.