The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0752-2023·Announced 2022-12-28

GE Vivid S5 Ultrasound Systems Battery Failure Fire Risk

GE Medical Systems is recalling Vivid S5 ultrasound systems because batteries may fail if not replaced at the recommended 2-year intervals, potentially causing smoke or 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 medical device recall involving potential battery failure with fire and smoke hazard. No illnesses, injuries, or reported incidents. Hazard is theoretical but serious.

Plain-English summary

GE Medical Systems, LLC is recalling Vivid S5 ultrasound systems used for diagnostic ultrasound imaging. Approximately 5,649 units have been distributed worldwide, including throughout all US states and territories.

The recall addresses a battery safety concern. Batteries that are not replaced at the 2-year interval recommended in the Service Manual may fail and could emit smoke or catch fire.

Affected users should review their device maintenance records to determine if batteries have been replaced according to the Service Manual schedule. Healthcare facilities and individual operators should contact GE Medical Systems for guidance on battery replacement procedures and any necessary service actions.

The recalled product

Product
Vivid S5 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 — Ultrasound Systems
Hazard
Affected units
5,649

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): H45021LC (VS50873
  • VS51169
  • VS5227
  • VS594
  • VS5289
  • VS544
  • VS5155
  • VS50058
  • VS519
  • VS551
  • VS50589
  • VS5286
  • VS5317
  • VS5299
  • VS50954
  • VS50940
  • VS560
  • VS50793
  • VS50311
  • VS50028

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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