Reported Dec 19, 2018 · Terminated
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician 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 LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular).
- Lot codes and dates
103 of 103 codes
Serial numbers 500055US7500103US7500022US7500059US700066US7500083US7500057US7500130US7500114US7500105US7500111US7500039US7500132US7500064US7500128US7500131US7500063US7500062US7500104US7500139US7500126US7500127US7500125US7500138US7500140US7500095US7500099US7500100US7500102US7500097US7500060US7500020US7500002US7500019US7500093US7500003US7500004US7500005US7500065US7500072US7500058US7500049US7500050US7500047US7500035US7500021US7500023US7500024US7500025US7500026US7500007US7500008US7500009US7500010US7500013US7500014US7500016US7500017US7500012US7500029US7
- Amount recalled
- 103 devices(64 US; 39 OUS)
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
This product could cause temporary or reversible health problems — stop using it.
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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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