GE Healthcare MAC VU360 Electrocardiograph Recall: Patient ID Errors
GE Healthcare recalls MAC VU36: Electrocardiograph model 2030360 001 due to incorrect patient identification and demographic errors. Affected users should contact GE Healthcare for details.
Lower-risk recall
Incorrect patient identification and/or patient demographic errors.
Contact the company
What happened, in plain English
GE Healthcare is recalling its MAC VU360 electrocardiograph (model 2030360 001) because it can cause incorrect patient identification and demographic errors. This could lead to misdiagnosis or treatment errors if the device is used without proper verification. Read more at govinfonow.com/recall/64049-ge-healthcare-mac-vu360-electrocardiograph-recall-patient-id-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/64049-ge-healthcare-mac-vu360-electrocardiograph-recall-patient-id-errors · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0543-2021
Cite this page
“GE Healthcare MAC VU360 Electrocardiograph Recall: Patient ID Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64049-ge-healthcare-mac-vu360-electrocardiograph-recall-patient-id-errors. Based on FDA recall #Z-0543-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0543-2021%22&limit=1).
Why it’s dangerous
The device may misidentify patients or record incorrect demographic information, potentially leading to misdiagnosis or inappropriate treatment. This error could occur during routine patient monitoring if the device is not properly configured or calibrated.
Who’s affected
Healthcare providers using the MAC VU360 electrocardiograph for patient monitoring are most at risk. The device is typically used in medical settings where accurate patient identification is critical.
How to tell if you have this one
Check for the model number 2030360 001 on the MAC VU360 electrocardiograph. This device was sold by GE Healthcare for medical use.
- Brand
GE Healthcare- Category
Medical device
What to do — step by step
Contact GE Healthcare
Reach out to GE Healthcare directly to confirm if your device is affected and get instructions for next steps.
Where it went and when
Where it was distributed
Distributed in 48 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “Domestic 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. International…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0543-2021 (October 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0543-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.