MAC VU360 — Class II medical device recall Z-0543-2021
Terminated recall by GE Healthcare, LLC, reported 2020-12-16, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Incorrect patient identification and/or patient demographic errors.
| Recall number | Z-0543-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-10-27 |
| Classified | 2020-12-07 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2024-05-03 |
| Distributed | 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 |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IT, KR, KW, MX, NL, NO, NZ, QA, SE, SG, TH |
| Quantity | 5,284 units |
| Model numbers | 001, 2030360 |
Product
MAC VU360, Electrocardiograph
Reason for recall
Incorrect patient identification and/or patient demographic errors.
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-0543-2021. 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.