Recall Z-2731-2016— GE Healthcare, LLC

Name: FDA recall Z-2731-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-31

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2016-08-31, terminated 2018-07-31. It names one FDA 510(k) clearance: K143251. Product: GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.. Reason: GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-08-31
Terminated: 2018-07-31
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K143251 — SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)·cleared 2015-02-04

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 SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.

Reason for recall

GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.

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