Reported Dec 28, 2022 · Ongoing

Vivid S6 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 S6 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 (System ID)

    708 of 708 codes

    • H45551WB (VS6500
    • VS6440
    • VS60642
    • VS60584
    • VS6176
    • VS6495
    • VS6491
    • VS6396
    • VS6230
    • VS6MB0222
    • VS60208
    • VS698
    • DZ2175US02
    • DZ1343US01
    • DZ2174US01
    • 911367260
    • 030070US04
    • BW6007US01
    • VS63016VS6
    • VS60286VS6
    • VS62394VS6
    • VS63516VS6
    • VS60256VS6
    • VS63523VS6
    • VS60317VS6
    • VS62266VS6
    • V2085AD
    • BG4042US02
    • 905577VS6A
    • 905566VS6
    • 514843AVS6A
    • 604520VS6A
    • 705743VS6
    • 416431VS6
    • 416920VS6
    • 416665VS6
    • 416233VS6
    • 519890VS6
    • 519739VS6A
    • VS63924VS6
    • VS64507VS6
    • EG5631US01
    • FI1010US06
    • U421740701
    • US26664720
    • US60509705
    • USN4186702
    • US20768611
    • U160416403
    • U260793002
    • 149431U005
    • 2117508U01
    • 2216997U02
    • 1040088U02
    • 140580U003
    • 149430U001
    • 800158U006
    • HU1015US11
    • A5812265
    • 0850US5619
Amount recalled
708 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, 5:40 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.