Z-0755-2023Class II

Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics...

Name: Z-0755-2023 Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics...
Creator: GE Medical Systems, LLC
Published: 2022-11-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-11-10 / Open, Classified / root cause: design

FDA source

GE Medical Systems, LLC began a recall of Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast... on 2022-11-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0755-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-10
Posted: 2022-12-22
Recalling firm: GE Healthcare
Product: 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).
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare notified consignees on about 11/10/2022 via letter titled "URGENT MEDICAL DEVICE CORRECTION. For U.S. customers, letters were sent via FedEx. Consignees were instructed to follow updated safety instructions provided in the appendix included with the notification letter, place the appendix with the product labeling, and replace the batter every 2 years or if the battery is not capable of powering the system for more than 30 minutes. In response, GE Healthcare requested consignees return the response form.
Quantity in commerce: 708 units
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
Product codes and lots: No US Distribution. 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0755-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0752-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0753-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0754-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0755-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0756-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0757-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0758-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0759-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22

Product code IYN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)