The Recall Desk
HighFDA (Devices)·Z-0759-2023·Announced 2022-12-28

Ultrasound System Batteries May Fail, Emit Smoke, or Catch Fire

GE Medical Systems is recalling Vivid q N ultrasound systems due to potential battery failures that could emit smoke or catch fire if batteries are not replaced per the 2-year service manual recommendation.

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 medical device recall for fire and smoke hazard from battery failure. No reported injuries or incidents, making this a risk-of-harm scenario where preventive maintenance is specified. Meets the rubric criterion for high-severity recalls where potential for serious harm exists but injury has not yet been reported.

Plain-English summary

GE Medical Systems, LLC is recalling approximately 250 Vivid q N ultrasound systems due to a potential battery hazard. The devices were distributed worldwide.

The Vivid q N is an ultrasound imaging system used for diagnostic imaging in applications including obstetrics, abdominal imaging, pediatric care, cardiac imaging, vascular imaging, and other clinical specialties. According to the FDA, batteries in these systems that have not been replaced at the 2-year interval recommended in the Service Manual can fail, potentially emitting smoke or catching fire.

Healthcare facilities using affected systems should verify that battery replacement has been performed according to the 2-year maintenance schedule specified in the manufacturer's Service Manual. Operators or facility managers should contact GE Medical Systems to verify their system's battery replacement status and to report any battery-related incidents.

The FDA classified this as a Class II recall, indicating a potential serious health hazard. No patient injuries or incidents have been reported in association with this issue.

The recalled product

Product
Vivid q 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-skelet
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Ultrasound System
Hazard
Affected units
250

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): H45571BK (DZ1315US08
  • VQ50927VQ
  • 835385929
  • 0835385937
  • IQ1398US05
  • IQ1398US04
  • IQ1398US03
  • IQ1398US02
  • A6193101
  • JO4026US01
  • JO4034US01
  • KE1070US01
  • KW1018US27
  • KT1066US01
  • LY1076US02
  • OM1000US04
  • OM1042US09
  • OM1042US08
  • OM1010US10
  • PK1367US01

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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