GE Medical Systems recalls Venue Fit R3, R4, and R5 ultrasound systems with specific model numbers due to potential battery failure causing smoke or fire. Affected units include China versions and certain serial numbers.
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
GE Medical Systems is recalling Venue Fit R3, R4, and R5 ultrasound systems because the battery can fail internally and cause smoke or fire. This hazard affects specific model numbers and versions sold in China.
The battery in certain ultrasound systems can develop an internal failure that may lead to smoke or fire. This hazard occurs during normal use and could pose a fire risk if the system is left unattended.
Medical professionals and healthcare facilities that own or use the affected Venue Fit ultrasound systems are most at risk. The recall includes specific model numbers and versions sold in China.
Check if your system has model numbers H45303VFSC, H45303VFSW, H45314VFS, H45314VFSW, H45335VFS, or H45335VFSW. Also, look for China-specific versions like R3 Surgery, PeriOP, Expert, Pro, Performance, or Intervention. The recall includes specific serial numbers and GTINs listed in the official notice.
Review your system's model number and serial number to confirm if it's affected. The recall includes specific model numbers and versions sold in China.
Reach out to GE Medical Systems for guidance on next steps and potential remedies. They will provide instructions for affected units.
The recall affects Venue Fit R3 (model numbers H45303VFSC, H45303VFSW), R4 (model numbers H45314VFS, H45314VFSW), and R5 systems (model numbers H45335VFS, H45335VFSW), as well as China-specific versions like R3 Surgery, PeriOP, Expert, Pro, Performance, and Intervention.
No immediate stop is required. The hazard is low risk and does not cause serious injury in normal use. Affected units should be checked and contacted with GE for guidance.
Check your system's model number and serial number against the list of affected units provided in the recall notice. China-specific versions are also included in the recall.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1556-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-1556-2025 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
