RecallRadar

FDA Device recall Z-1849-2013

GE Healthcare, LOGIQ e Ultrasound System

On 2013-08-07 the FDA classified a Class II recall of GE Healthcare, LOGIQ e Ultrasound System by Ge Healthcare, citing GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1849-2013
ClassificationClass II
Statusterminated
Initiated2012-11-09
Published2013-08-07
Last updated2026-09-13 11:53 UTC
CompanyGe Healthcare
DistributionUS

Product

GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Reason

GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.

Identifiers

code_info
Mfg Lot or Serial # 223133WX0 223134WX8 223135WX5 223136WX3 223137WX1 224634WX6 224635WX3 224636WX1 224637WX9…Mfg Lot or Serial # 223133WX0 223134WX8 223135WX5 223136WX3 223137WX1 224634WX6 224635WX3 224636WX1 224637WX9 224638WX7 224639WX5 224640WX3 224641WX1 224642WX9 224643WX7 224644WX5 224645WX2 224786WX4 224787WX2 224788WX0 224789WX8 224790WX6 224791WX4 224792WX2 224793WX0 224794WX8 224795WX5 224796WX3 224797WX1 224798WX9 224799WX7 224800WX3 224801WX1 224802WX9 224803WX7 224804WX5 224805WX2 224806WX0 224807WX8 224808WX6 224951WX4 225010WX8 225011WX6 225012WX4 225013WX2 225014WX0 225015WX7 225143WX7 225144WX5 225145WX2 225146WX0 226933WX0 226934WX8 226935WX5 226936WX3 226937WX1 227218WX5 227219WX3 227221WX9 227222WX7 227223WX5 227224WX3 227225WX0 227226WX8 227227WX6 227228WX4 227229WX2 227230WX0 227231WX8 227232WX6 227233WX4 227279WX7 227280WX5 227281WX3 227282WX1 227283WX9 227284WX7 227285WX4 227286WX2 227287WX0 227288WX8 227574WX1 227575WX8 227576WX6 227577WX4 227578WX2 228256WX4 228257WX2 228258WX0

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1849-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.