Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GY

FDA device recall Z-0754-2023 · posted 2022-12-22 · Open, Classified

Recall details

Recalling firm

GE Medical Systems, LLC

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

IYN

Quantity affected

1,400 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

Date initiated

2022-11-10

Date posted

2022-12-22

Location

Waukesha, WI