FDA Device recall Z-0543-2021
MAC VU360, Electrocardiograph
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of MAC VU360, Electrocardiograph by Ge Healthcare, citing incorrect patient identification and/or patient demographic errors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0543-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-27 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
MAC VU360, Electrocardiograph
Reason
Incorrect patient identification and/or patient demographic errors.
Identifiers
| code_info | Model: 2030360 001 |
|---|
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-0543-2021%22
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