Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system

FDA device recall Z-1556-2025 · posted 2025-04-11 · Open, Classified

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

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

Action taken

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/6/25 was sent to customers. Actions to be taken by Customer/User: You can continue to use your Venue Go and Venue Fit system after following the actions below: 1) Turn the system Off and unplug the system from the wall socket. 2) Remove the system batteries by following instructions provided in the User Manual Chapter 3. These instructions are also provided in this letter in Appendix A for Venue Go and in Appendix B for Venue Fit. 3) Check the date of manufacture of the system batteries by looking at the label on the bottom of each battery (See Figure 1). The date of manufacture is displayed as YYYY-MM for year and month of manufacture. NOTE: Venue Go has two batteries and Venue Fit has one battery 4) Calculate the age of each of the system batteries. 5) If any of the batteries are more than 2 years old: a. With the system unplugged, re-insert batteries, turn the system On and leave the system On to discharge the batteries. b. Once the battery capacity indicator shows two segments or less (See Figure 2), turn the system Off and remove the batteries per step 2. c. Dispose of batteries according to local regulations. NOTE: After battery removal, you can continue to use the system with use of AC power cord. The system is fully functional without the battery. 6) If the batteries are less than 2 years old, you may continue to use the battery until the battery reaches 2 years old, at which point, repeat instructions in step 5. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.78101@gehealthcare.com. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. After the correction has been implemented, please be sure to destroy

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

IYN

Quantity affected

12,808 total systems

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2025-03-06

Date posted

2025-04-11

Location

Waukesha, WI

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