GE Medical Systems, LLC: Device Recall

Recall Details

Recall Number

Z-1556-2025

Classification

Class II

Product Type

Device

Recalling Firm

GE Medical Systems, LLC

Status

Ongoing

Date Initiated

03/06/2025

Location

Waukesha, WI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

12,808 total systems

Reason for Recall

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

Product Description

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 Intervention for China diagnostic ultrasound systems

Distribution Pattern

Worldwide - US Nationwide distribution.

Other Recalls by GE Medical Systems, LLC

• Class II: Risk 10/24/2025
  Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
• Class II: Risk 09/18/2025
  The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
• Class II: Risk 09/18/2025
  The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
• Class II: Risk 09/18/2025
  The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
• Class II: Risk 08/22/2025
  If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

View all recalls by GE Medical Systems, LLC →