Recall Z-0756-2023— GE Medical Systems, LLC

Name: FDA recall Z-0756-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-10

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2022-11-10. It names 5 FDA 510(k) clearances: K102388, K092140, K082374 and 2 more. Product: Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).. Reason: Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-11-10
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

5 on FDA's record

K102388 — VIVID I DIAGNOSTIC ULTRASOUND SYSTEMGe Medical System Israel , Ltd.·cleared 2010-11-04
K092140 — GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUNDGe Medical Systems Israel, Ultrasound, Ltd.·cleared 2009-08-21
K082374 — VIVID I AND VIVID QGe Medical Systems Israel, Ultrasound, Ltd.·cleared 2008-09-02
K061525 — GE VIVID - IGeneral Electric Co.·cleared 2006-07-03
K033139 — GE MARLIN ULTRASOUNDGeneral Electric Co.·cleared 2003-10-23

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

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Reason for recall

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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