The Recall Desk
HighFDA (Devices)·Z-0753-2023·Announced 2022-12-28

GE Vivid S6 Ultrasound Systems Recalled for Battery Fire Risk

GE Vivid S6 ultrasound systems are recalled for a potential battery hazard. If not replaced at the recommended 2-year interval, batteries may fail, emit smoke, or catch fire.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is theoretical—batteries may fail or emit smoke or fire if not replaced at the recommended 2-year interval. Per the rubric, this represents a risk-of-harm product without reported injury, warranting a score of 3 (High).

Plain-English summary

GE Medical Systems is recalling Vivid S6 ultrasound systems, which are used in various medical imaging applications including fetal and obstetric imaging, cardiac imaging, and abdominal imaging. The recall affects 5,145 units with worldwide distribution.

The recall addresses a potential safety hazard involving the system's batteries. Batteries that have not been replaced at the 2-year interval recommended in the manufacturer's Service Manual can fail or potentially emit smoke or catch fire, posing a fire hazard in clinical settings.

Users and facility managers should verify that batteries in affected systems have been replaced according to the manufacturer's maintenance schedule. Consult the Service Manual for proper battery replacement procedures and timing.

The recalled product

Product
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 Superf
Manufacturer
GE Medical Systems, LLC
Hazard
  • fire
  • smoke
  • battery-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model Number (System ID): H45021LD (VS6R0610
  • VS60368
  • VS6253
  • VS6229
  • VS60870
  • VS60838
  • VS627
  • VS671
  • VS6332
  • VS60647
  • VS629
  • VS60084
  • VS6302
  • VS674
  • VS6423
  • VS6411
  • VS6R0161
  • VS6634
  • VS682
  • VS60841

Distribution

Distributed nationwide across the United States.