Recall Z-0753-2023 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Medical Systems, LLC
Vivid S6 ultrasound. 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, a
| Date | Dec 22, 2022 (initiated Nov 10, 2022) |
| Status | Open, Classified |
| Reason | 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 | 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 | 5,145 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 Afghan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071985 | GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND General Electric Co., Aug 17, 2007 |
| K092079 | MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND Ge Medical Systems Israel, Ultrasound, Ltd., Aug 6, 2009 |
| K102393 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM Ge Medical System Israel , Ltd., Nov 5, 2010 |
| K121063 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM Ge Medical System Israel , Ltd., Aug 21, 2012 |