Reported Dec 28, 2022 · Ongoing
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062).…
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 ultrasound. Marketed
- under the following 510(k) numbersK033139, K061525, K082374, K092140, K102388, K121062). 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
- Model Number (System ID)
3,202 of 3,202 codes
H45021A (VI4552VI351)H45021AF (VI1246VI327VI1415VI256VI00887VI1119VI000832VI0468VI666VI1658VI1263VI1676VI1673VI1261VI689VI921VI1148VI511VI050852VI1295VI1166VI1247VI1536VI730VIMB00435VI431VI2397VI1029VI554VI1020VI0658VI1432VI51073VI880VI1199VI994AVHSE20751VI311VI379VI1256VI1214VI345VI193VI336VI1097VI853VI1488VI848VI1017VI739VI1258VI248VI732VI148VI1410VI1234VI697VIR55546
- Model Number (System ID)
- Amount recalled
- 7,931 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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