The Recall Desk
HighFDA (Devices)·Z-0754-2023·Announced 2022-12-28

Vivid S5 N Ultrasound Systems Recalled for Potential Battery Fire Hazard

GE Medical Systems recalled 1,400 Vivid S5 N ultrasound systems for batteries that may fail, emit smoke, or catch fire if not replaced every 2 years as recommended.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—batteries may fail, emit smoke, or catch fire—but no actual incidents have been reported. This meets the High severity criterion for risk-of-harm products with unreported injury.

Plain-English summary

GE Medical Systems, LLC has issued a recall of approximately 1,400 Vivid S5 N ultrasound systems. These medical imaging devices are used for a wide range of diagnostic ultrasound procedures including fetal and obstetrics, abdominal imaging, cardiac evaluation, and vascular assessment.

The recall is due to a potential battery hazard. Batteries that have not been replaced at the 2-year interval recommended in the Service Manual can fail, potentially emit smoke, or catch fire.

Healthcare facilities and medical professionals using these systems should verify that replacement batteries have been installed according to the manufacturer's service schedule. For replacement instructions and components, contact GE Medical Systems.

The recalled product

Product
Vivid S5 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
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Ultrasound Imaging System
Hazard
Affected units
1,400

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): H45551WC (VS50226
  • VS5226
  • VS50038
  • VS593
  • VS5R34
  • VS50101
  • VS515
  • VS50086
  • VS5302
  • VS50040
  • VS50001
  • VS5251
  • VS50109
  • VS5R17
  • AF1025US01
  • DZ1318US01
  • DZ2655US02
  • DZ1312US01
  • DZ1291US01
  • DZ1282US01

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 →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · battery failure

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