Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MAC VU360 Recalled by GE Healthcare, LLC Due to Two issues: 1) The MAC VU360 system may...

Date: June 28, 2019
Company: GE Healthcare, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.

Affected Products

MAC VU360, Model Number 2030360-001, Electrocardiograph

Quantity: 369 units

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide

About GE Healthcare, LLC

GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report