Recall Z-0131-2021— GE Healthcare, LLC

Name: FDA recall Z-0131-2021
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 one FDA 510(k) clearance: K163619. Product: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.. 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

1 on FDA's record

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

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

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

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.