MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu

FDA device recall Z-0231-2026 · posted 2025-10-22 · Open, Classified

Recall details

Recalling firm

GE Medical Systems, LLC

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.

Action taken

An "URGENT MEDICAL DEVICE CORRECTION" notification letter dated 8/22/25 was sent to customers. Actions to be taken by Customer/User: You can continue to use your device in accordance with the instructions in the MAC VU360 Operator Manual and the actions described below: 1. Inspect all potentially affected devices for the presence of damage to the Acquisition Trunk Cable per the MAC VU360 Operator Manual (P/N 2088531-202, Section 11). 2. If the Acquisition Trunk Cable shows damage, remove the cable from service. 3. Ensure the Acquisition Module is placed correctly in the Acquisition Module Holder and that the Acquisition Trunk Cable is not pinched during insertion. See section 1.3 of the MAC VU360 V1.03 Setup and Configuration Manual (P/N 2088531-204). Note: Manuals can be accessed from the GE HealthCare Customer Documentation Portal at https://www.gehealthcare.com/support/manuals 4.Please complete and return the attached acknowledgement form to DCAR.Recall@gehealthcare.com GE HealthCare will provide a customer-installable kit containing a new Acquisition Trunk Cable and a redesigned Acquisition Module Holder for the affected devices at no cost to you. Please make sure all potential users in your facility are made aware of this safety notification and the recommended actions. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Device Design

Status

Open, Classified

Product code

DPS

Quantity 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, I

Date initiated

2025-08-22

Date posted

2025-10-22

Location

Waukesha, WI

Related 510(k) clearances