Recall Z-1488-2014— GE Healthcare, LLC

Name: FDA recall Z-1488-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-27

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-03-27, terminated 2015-01-14. It names one FDA 510(k) clearance: K131514. Product: GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.. Reason: GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-03-27
Terminated: 2015-01-14
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K131514 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMGe Vingmed Ultrasound AS·cleared 2013-07-12

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 Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.

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