MAC VURecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

3 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. Jun 29, 2026Open, Classified

   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.

   Z-2876-2026 · Root cause: Software design · FDA record ↗

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-0231-2026 · Aug 22, 2025 · Open, Classified
  MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
• Z-0543-2021 · Oct 27, 2020 · Terminated
  MAC VU360, Electrocardiograph
• Z-2060-2019 · Jun 28, 2019 · Terminated
  MAC VU360, Model Number 2030360-001, Electrocardiograph