Recall Z-0231-2026— GE Medical Systems, LLC

Name: FDA recall Z-0231-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-22

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-08-22. It names one FDA 510(k) clearance: K173830. Product: MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4. Reason: 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..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-08-22
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K173830 — MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.·cleared 2018-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.