The Recall Desk
HighFDA (Devices)·Z-1556-2025·Announced 2025-04-23

[pending] Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW),

Pending LLM rewrite. Source: FDA_DEVICE Z-1556-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

The recalled product

Product
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervent
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Devices

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 (9)

  • UDI-DI: Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400)
  • Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503)
  • Venue Fit R3 Surgery for China (GTIN 00195278552488)
  • Venue Fit R3 PeriOP for China (GTIN 00195278552501)
  • Venue Fit R3 Expert for China (GTIN 00195278552402)
  • Venue Fit R3 Pro for China (GTIN 00195278552419)
  • Venue Fit R3 Performance for China (GTIN 00195278552440)
  • Venue Fit R3 Intervention for China (GTIN 00195278552495)
  • Venue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041)

Distribution

Distributed nationwide across the United States.

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