MAC VU360Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682125499), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K173830); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 22, 2025Open, Classified

   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.

   Z-0231-2026 · Root cause: Device Design · FDA record ↗

2. Jun 28, 2019Terminated

   Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.

   Z-2060-2019 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2020Smoking; Sparking; Device Handling Problem; Device Handling Problem

  THE CUSTOMER ALLEGED A SPARK AND SMOKE OCCURRED ON THE CABLE THAT RUNS BETWEEN THE ACQUISITION MODULE (CC14) AND THE MAC VU360 WHILE CONNECTED TO A PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10546865 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173830. One submission often covers many models, so check the product and lot details in each record.

• Z-2876-2026 · Jun 29, 2026 · Open, Classified
  GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
• Z-0543-2021 · Oct 27, 2020 · Terminated
  MAC VU360, Electrocardiograph