FDA Device recall Z-2060-2019
MAC VU360, Model Number 2030360-001, Electrocardiograph
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of MAC VU360, Model Number 2030360-001, Electrocardiograph by Ge Healthcare, citing 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 E….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2060-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-28 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
MAC VU360, Model Number 2030360-001, Electrocardiograph
Reason
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.
Identifiers
| code_info | UDI # Serial # 840682125499VU218440023SA VU218440023SA 840682125499VU218440030SA VU218440030SA 840682125499VU2184500…UDI # Serial # 840682125499VU218440023SA VU218440023SA 840682125499VU218440030SA VU218440030SA 840682125499VU218450037SA VU218450037SA 840682125499VU218450041SA VU218450041SA 840682125499VU218450042SA VU218450042SA 840682125499VU219170004SA VU219170004SA 840682125499VU219130019SA VU219130019SA 840682125499VU219130032SA VU219130032SA 840682125499VU219130039SA VU219130039SA 840682125499VU219130044SA VU219130044SA 840682125499VU219120048SA VU219120048SA 840682125499VU219120052SA VU219120052SA 840682125499VU219120060SA VU219120060SA 840682125499VU219140016SA VU219140016SA 840682125499VU218440018SA VU218440018SA 840682125499VU219140001SA VU219140001SA 840682125499VU219140005SA VU219140005SA 840682125499VU219120044SA VU219120044SA 840682125499VU219120049SA VU219120049SA 840682125499VU219120054SA VU219120054SA 840682125499VU219120055SA VU219120055SA 840682125499VU219120056SA VU219120056SA 840682125499VU219120012SA VU219120012SA 840682125499VU219120014SA VU219120014SA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2060-2019%22
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