Reported Dec 28, 2022 · Ongoing

Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics;…

GE Medical Systems, 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 Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • Vivid i N ultrasound. Not marketed in the US. 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).
Lot codes and dates
  • No US Distribution. Model Number H45561AC
  • System ID

    113 of 113 codes

    • DZ1237US02
    • AO1015US01
    • EG1843US01
    • EG5882US01
    • EG1621US04
    • EG1621US03
    • 2538978U01
    • 083038042857318
    • 083038602007811
    • 083038602826113
    • 0835384095
    • IQ1165US05
    • IQ1376US01
    • KE1049US01
    • KW1010US04
    • KW1102US04
    • KW1001US35
    • KW1011US21
    • KW1011US22
    • KW1006US14
    • KW1098US06
    • KW1020US15
    • KT1061US01
    • KT1062US02
    • LB1359US04
    • 1553UL1026
    • 0834380243
    • 0834384085
    • 0834384095
    • MA1251US13
    • MA1272US10
    • OM1042US03
    • OM1007US11
    • OM1007US12
    • PK1331US08
    • PK1331US06
    • PA1097US01
    • SA1201US02
    • SA1014US07
    • SA1337US05
    • SA1060US08
    • SA1147US05
    • SA1149US03
    • SA1051US09
    • SA2220US02
    • SA2220US01
    • SA2072US17
    • SA1028US06
    • SA1089US07
    • SA1138US05
    • SA2158US07
    • SA1340US02
    • SA1223US15
    • SA1002US08
    • SA1036US06
    • SA1025US03
    • SA2214US03
    • SA1272US10
    • SA1024US04
    • SA1101US04
Amount recalled
113 units

This recall covers 15 products

The agency filed one notice per product. You are reading one of them; the other 14 are below.

2 more are in the archive.

Where it was sold

Why it was recalled

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.

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.