Recall Z-0231-2026 ยท DPS Electrocardiograph
GE Medical Systems, LLC
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
| Date | Oct 22, 2025 (initiated Aug 22, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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 Hol |
| Quantity | 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, Philipp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173830 | MAC VU360 Resting ECG Analysis System Ge Medical Systems Information Technologies, Inc., Sep 18, 2018 |