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
DZ1237US02AO1015US01EG1843US01EG5882US01EG1621US04EG1621US032538978U010830380428573180830386020078110830386028261130835384095IQ1165US05IQ1376US01KE1049US01KW1010US04KW1102US04KW1001US35KW1011US21KW1011US22KW1006US14KW1098US06KW1020US15KT1061US01KT1062US02LB1359US041553UL1026083438024308343840850834384095MA1251US13MA1272US10OM1042US03OM1007US11OM1007US12PK1331US08PK1331US06PA1097US01SA1201US02SA1014US07SA1337US05SA1060US08SA1147US05SA1149US03SA1051US09SA2220US02SA2220US01SA2072US17SA1028US06SA1089US07SA1138US05SA2158US07SA1340US02SA1223US15SA1002US08SA1036US06SA1025US03SA2214US03SA1272US10SA1024US04SA1101US04
- 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.
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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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