PlainRecalls
FDA Devices Moderate Class II Ongoing

MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

Reported: October 29, 2025 Initiated: August 22, 2025 #Z-0231-2026

Product Description

MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

Reason for Recall

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.

Details

Recalling Firm
GE Medical Systems, LLC
Units Affected
29,225 units
Distribution
Worldwide Distribution: US (nationwide) and OUS (foreign/Global) to countries of: Australia, Austria, Bahrain, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4. Recalled by GE Medical Systems, LLC. Units affected: 29,225 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 29, 2025. Severity: Moderate. Recall number: Z-0231-2026.