MAC VU360 Resting ECG Analysis System

• • Ongoing Z-2876-2026 FDA Class II ·initiated 29 Jun 2026

  Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

• • Ongoing Z-0231-2026 FDA Class II ·initiated 22 Aug 2025

  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.

• • Terminated Z-0543-2021 FDA Class II ·initiated 27 Oct 2020

  Incorrect patient identification and/or patient demographic errors.

• • Terminated Z-2060-2019 FDA Class II ·initiated 28 Jun 2019 ·on shared 510(k) K173830

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K173830 ↗

FDA product code

DPS

Device class

Class II

Regulation

21 CFR Part 870.2340

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

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• What types of ECG leads does the MAC VU360 support, and how does this affect its clinical use?

  The MAC VU360 Resting ECG Analysis System supports both 12-lead and 15-lead ECG measurements, which expands its clinical utility. A 12-lead ECG is standard for most cardiac assessments, while the 15-lead option provides additional diagnostic detail, particularly for complex cases like bundle branch blocks or ventricular hypertrophy. This flexibility ensures compatibility with a wide range of patient evaluations in hospitals and cardiology departments.

• Is the MAC VU360 designed for single-use or reusable applications, and what does this mean for maintenance?

  The MAC VU360 is reusable and non-sterile, meaning it is intended for repeated use within a clinical setting after proper cleaning and maintenance. This design reduces waste and cost over time but requires adherence to manufacturer guidelines for disinfection and servicing to ensure accuracy and reliability of ECG interpretations. Hospitals must establish protocols for cleaning and calibration to maintain performance.

• How does the MAC VU360 integrate with other healthcare systems, and what are the benefits of this connectivity?

  The MAC VU360 is designed to integrate with central cardiovascular systems, enabling seamless data exchange between ECG analysis and broader patient monitoring platforms. This connectivity allows clinicians to access ECG results digitally, streamline workflows, and reduce manual transcription errors. It is particularly useful in large hospitals or cardiology departments where real-time data sharing and centralized reporting are critical for patient care.

• What regulatory pathways does the MAC VU360 follow, and how does this impact its use in different markets?

  The MAC VU360 has undergone FDA 510(k) clearance (K173830) and complies with MDR (Medical Device Regulation) standards, ensuring it meets stringent safety and performance requirements in both the U.S. and European markets. The FDA’s Substantially Equivalent (SESE) decision under the Cardiovascular (CV) advisory committee confirms its equivalence to a predicate device, while MDR compliance addresses broader EU regulatory demands. This dual approval simplifies procurement for healthcare providers operating across these regions.