Medical device recalls Moderate risk

MAC VU360 Acquisition Trunk Cable and Module Holder recalled over fire hazard

Recall date
August 22, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
GE Medical Systems, LLC recalls MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model N…
Recall number
Z-0231-2026
FDA classification
Class II
Brand / firm
GE Medical Systems, LLC
Sold / distributed
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, Philip…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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