Recall Z-0755-2023— GE Medical Systems, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2022-11-10. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-10
- Firm location
- Waukesha, WI, United States
Product description
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).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.