The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0758-2023·Announced 2022-12-28

Vivid i N ultrasound device batteries may fail, smoke, or catch fire

GE Medical Systems recalls Vivid i N ultrasound machines worldwide because unreplaced batteries may fail, emit smoke, or catch fire. Users should replace batteries every 2 years per the service manual.

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 device recall with no reported illnesses, injuries, or deaths. The hazard—battery failure leading to potential fire and smoke—is serious but theoretical. This meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems is recalling certain Vivid i N ultrasound systems worldwide due to a battery hazard. Batteries in these devices that have not been replaced at the recommended 2-year interval, as specified in the Service Manual, may fail, emit smoke, or catch fire.

This recall affects 113 units distributed globally, including throughout the United States. The Vivid i N is used in multiple imaging applications including fetal/obstetric, cardiac, vascular, and musculoskeletal imaging.

GE Medical Systems and the FDA recommend that facilities using affected ultrasound devices inspect them immediately and follow the 2-year battery replacement schedule specified in the Service Manual. Operators should contact their GE representative or the FDA for specific guidance on their device.

The recalled product

Product
Vivid i 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 Imaging Equipment
Hazard
Affected units
113

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 H45561AC
  • System ID: DZ1237US02
  • AO1015US01
  • EG1843US01
  • EG5882US01
  • EG1621US04
  • EG1621US03
  • 2538978U01
  • 083038042857318
  • 083038602007811
  • 083038602826113
  • 0835384095
  • IQ1165US05
  • IQ1376US01
  • KE1049US01
  • KW1010US04
  • KW1102US04
  • KW1001US35
  • KW1011US21
  • KW1011US22

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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