The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0757-2023·Announced 2022-12-28

GE Vivid q Ultrasound Systems: Battery Fire Risk Recall

GE is recalling Vivid q ultrasound systems because batteries not replaced every 2 years as recommended may fail and emit smoke or catch fire.

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: FDA Class II recall for a risk-of-harm medical device with potential fire and smoke hazards from battery failure. No reported illnesses, injuries, or deaths are mentioned in the source, making this a theoretical hazard that meets the criteria for High severity.

Plain-English summary

GE Medical Systems, LLC is recalling the Vivid q ultrasound system due to a battery hazard. The ultrasound system is used in clinical settings for imaging and analysis in multiple applications including fetal/obstetrics, abdominal/GYN, pediatric, cardiac, and other specialized imaging procedures.

Approximately 2,609 units have been distributed worldwide, including nationwide distribution across the United States. The recall addresses a hazard wherein batteries that have not been replaced at 2 years, as recommended in the Service Manual, may fail, emit smoke, or catch fire.

According to the Service Manual guidance, batteries should be replaced every 2 years to prevent potential failure. Affected customers should follow the battery replacement recommendations in their device's Service Manual.

The recalled product

Product
Vivid q 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…
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Ultrasound System
Hazard
Affected units
2,609

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): H45021WZ (VQ20056
  • VQ20718
  • VQ020015
  • VQ20399
  • VQ202400
  • VQ20127
  • VQ20529
  • VQ20505
  • VQ20502
  • VQ20533
  • VQ20741
  • VQ20683
  • VQ20653
  • VQ20700
  • VQ20580
  • VQ20477
  • VQ20498
  • VQ020516
  • VQ020216
  • VQ20507

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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