The Recall Desk
HighFDA (Devices)·Z-0756-2023·Announced 2022-12-28

GE Vivid i Ultrasound Systems Battery Failure Recall

GE Medical Systems is recalling Vivid i ultrasound systems because batteries not replaced every two years may fail, emit smoke, or catch fire. About 7,931 units were distributed worldwide.

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: This FDA Class II recall addresses a potential hazard—battery failure or fire in medical ultrasound equipment—that could impact patient or operator safety during diagnostic procedures. No injuries or illnesses have been reported; however, the hazard is tied directly to device functionality and occurs in clinical environments where equipment reliability is critical.

Plain-English summary

GE Medical Systems, LLC is recalling Vivid i ultrasound systems used for cardiac, obstetric, pediatric, and vascular imaging. The recall affects approximately 7,931 units distributed worldwide, including nationwide distribution across all US states and territories.

The ultrasound systems use batteries that may fail or emit smoke if not replaced at the two-year interval specified in the Service Manual. Continued operation with unreplaced batteries can result in battery failure or fire.

The recalled equipment is used in clinical settings for fetal, obstetric, abdominal, pediatric, neonatal, cardiac, peripheral vascular, musculoskeletal, urological, transesophageal, transrectal, and transvaginal imaging. Affected users should verify their device serial numbers against the FDA recall notice and follow replacement instructions provided by GE Medical Systems.

The recalled product

Product
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cepha
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Ultrasound Equipment
Hazard
Affected units
7,931

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): H45021A (VI4552
  • VI351)
  • H45021AF (VI1246
  • VI327
  • VI1415
  • VI256
  • VI00887
  • VI1119
  • VI000832
  • VI0468
  • VI666
  • VI1658
  • VI1263
  • VI1676
  • VI1673
  • VI1261
  • VI689
  • VI921
  • VI1148
  • VI511

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

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Same hazard · battery failure

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