Reported Aug 7, 2013 · Terminated
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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 includeFetal/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
- Lot codes and dates
- Mfg Lot or Serial #
588 of 588 codes
223133WX0223134WX8223135WX5223136WX3223137WX1224634WX6224635WX3224636WX1224637WX9224638WX7224639WX5224640WX3224641WX1224642WX9224643WX7224644WX5224645WX2224786WX4224787WX2224788WX0224789WX8224790WX6224791WX4224792WX2224793WX0224794WX8224795WX5224796WX3224797WX1224798WX9224799WX7224800WX3224801WX1224802WX9224803WX7224804WX5224805WX2224806WX0224807WX8224808WX6224951WX4225010WX8225011WX6225012WX4225013WX2225014WX0225015WX7225143WX7225144WX5225145WX2225146WX0226933WX0226934WX8226935WX5226936WX3226937WX1227218WX5227219WX3227221WX9227222WX7
- Mfg Lot or Serial #
- Amount recalled
- 588
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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