Reported Dec 28, 2022 · Ongoing

Vivid S5 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 S5 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)

    1,400 of 1,400 codes

    • H45551WC (VS50226
    • VS5226
    • VS50038
    • VS593
    • VS5R34
    • VS50101
    • VS515
    • VS50086
    • VS5302
    • VS50040
    • VS50001
    • VS5251
    • VS50109
    • VS5R17
    • AF1025US01
    • DZ1318US01
    • DZ2655US02
    • DZ1312US01
    • DZ1291US01
    • DZ1282US01
    • DZ1316US01
    • DZ3071US03
    • DZ1310US01
    • DZ1330US01
    • VS50470VS5
    • VS50515VS5
    • VS50847VS5
    • VS50507VS5
    • VS5472VS5
    • VS5453VS5
    • VS50485VS5
    • VS50152VS5
    • VS57140VS5
    • VS50561VS5
    • VS50520VS5
    • VS50517VS5
    • VS50766VS5
    • VS5512VS5
    • VS50026
    • BG4549US18
    • CM1073US01
    • CZ6731US01
    • CZ6289US02
    • EG6217US02
    • EG5403US01
    • EG5446US01
    • EG5401US01
    • EG5399US01
    • EG5416US01
    • EG5457US01
    • EG5478US01
    • EG5152US04
    • EG5001US09
    • EG5479US01
    • EG5465US01
    • EG5480US01
    • EG1387US02
    • EG5477US01
    • EG5560US02
    • EG5665US01
Amount recalled
1,400 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, 5:34 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.