The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0755-2023·Announced 2022-12-28

GE Vivid S6 N Ultrasound Battery Fire Risk Recall

GE Vivid S6 N ultrasound systems may experience battery failure, smoke, or fire if batteries are not replaced every 2 years as recommended. Clinicians should replace batteries per manufacturer Service Manual instructions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 for a theoretical fire and smoke hazard with no reported injuries or deaths. The rubric allows scores up to 3 for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems is recalling Vivid S6 N ultrasound systems due to a potential risk involving battery failure and fire. According to the manufacturer, batteries that have not been replaced at 2 years, as recommended in the Service Manual, can fail or possibly emit smoke or catch fire.

The Vivid S6 N is used in clinical ultrasound applications including fetal/obstetric, abdominal, cardiac, vascular, and musculoskeletal imaging. Approximately 708 units have been distributed.

Healthcare facilities using affected Vivid S6 N systems should ensure that all batteries are replaced every 2 years in accordance with the manufacturer's Service Manual recommendations. Users should review their equipment for compliance with battery replacement schedules and contact GE Medical Systems with any questions about battery maintenance procedures.

The recalled product

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…
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Ultrasound System
Hazard
Affected units
708

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)

  • No US Distribution. Model Number (System ID): H45551WB (VS6500
  • VS6440
  • VS60642
  • VS60584
  • VS6176
  • VS6495
  • VS6491
  • VS6396
  • VS6230
  • VS6MB0222
  • VS60208
  • VS698
  • DZ2175US02
  • DZ1343US01
  • DZ2174US01
  • 911367260
  • 030070US04
  • BW6007US01
  • VS63016VS6
  • VS60286VS6

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 8 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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