MAC VU360 — Class II medical device recall Z-2060-2019
Terminated recall by GE Healthcare, LLC, reported 2019-07-31. Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the
| Recall number | Z-2060-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-06-28 |
| Classified | 2019-07-23 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2021-04-13 |
| Quantity | 369 units |
| UPC / GTIN / UDI-DI | 00840682125499 |
| Serial numbers | 840682125499VU217420006SA, 840682125499VU218150005SA, 840682125499VU218160009SA, 840682125499VU218160012SA, 840682125499VU218160015SA, 840682125499VU218170002SA, 840682125499VU218170022SA, 840682125499VU218190010SA, 840682125499VU218190016SA, 840682125499VU218190017SA, 840682125499VU218200003SA, 840682125499VU218200006SA, 840682125499VU218200012SA, 840682125499VU218200013SA, 840682125499VU218200018SA, 840682125499VU218200019SA, 840682125499VU218200020SA, 840682125499VU218200024SA, 840682125499VU218200029SA, 840682125499VU218200030SA, 840682125499VU218200031SA, 840682125499VU218200032SA, 840682125499VU218200033SA, 840682125499VU218200034SA, 840682125499VU218210001SA and 475 more |
| Model numbers | 2030360-001 |
Product
MAC VU360, Model Number 2030360-001, Electrocardiograph
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2060-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.