Recall Z-1096-2013— GE Healthcare, LLC

Name: FDA recall Z-1096-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-08

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-02-08, terminated 2013-11-21. It names 2 FDA 510(k) clearances: K122114, K111582. Product: GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.. Reason: GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-02-08
Terminated: 2013-11-21
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K122114 — LOGIQ S7 EXPERT, LOGIQ S7 PROGE Healthcare·cleared 2012-10-03
K111582 — LOGIQ S8GE Healthcare·cleared 2011-07-26

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 LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.

Reason for recall

GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso

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