GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
FDA device recall Z-2876-2026 · posted 2026-08-04 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Reason for recall
- 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.
- Action taken
- GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 6/29/2026 via US mail. The notice explained the issue, potential risk, and requested the following: 'Actions to be taken by Customer/User You can continue to use your device. Pending corrections from GE HealthCare, after pressing the Order Refresh icon do not rely on automatic closure of the Preview and or Review screen when: " patient has been disconnected, and " at least 2 minutes of system inactivity If this occurs, do the following to clear all patient information data: " On the Preview screen, select Reject > Start New Patient " On the Review screen, select Done > Start New Patient NOTE: Be certain Start New Patient is selected to clear all patient information data. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 30123 Digital Response Form or print, fill out manually, scan, and email to DCAR.Recall@gehealthcare.com." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DPS
- Quantity affected
- 163 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK.
- Date initiated
- 2026-06-29
- Date posted
- 2026-08-04
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAC VU360 Resting ECG Analysis System (K173830) | Ge Medical Systems Information Technologies, Inc. | 2018-09-18 |