Z-0543-2021Class II

MAC VU360, Electrocardiograph

Name: Z-0543-2021 MAC VU360, Electrocardiograph
Creator: GE Healthcare, LLC
Published: 2020-10-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-10-27 / Terminated

FDA source

GE Healthcare, LLC began a recall of MAC VU360, Electrocardiograph on 2020-10-27. FDA classified it as Class II and gives the reason as "Incorrect patient identification and/or patient demographic errors". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0543-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-27
Posted: 2020-12-07
Terminated: 2024-05-03
Recalling firm: GE Healthcare
Product: MAC VU360, Electrocardiograph
Product code: DPS Electrocardiograph
Reason for recall: Incorrect patient identification and/or patient demographic errors.
FDA root cause: Use error
Action: On 10/27/2020 the firm sent a letter to its consignees with the following instructions: You can continue to use your MAC VU360 system: At system setup: -Disable Auto-ECG in System Settings until the software has been upgraded. When performing ECGs: - Ensure the current patient lead wires are disconnected before selecting the Start New Patient workflow in the user interface. - Verify there are live scrolling waveforms on the screen before acquiring an ECG on the patient. - Verify the date and time of the ECG report corresponds to the patient for whom you are acquiring the ECG. - Always enter patient demographic data for each patient before acquiring an ECG GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the MAC VU360 software to be updated. Providing GE Healthcare with an email address in the attached customer response form, allows us to deliver this software update to you electronically and provide you with notifications of future software updates, as they become available. Note: After the MAC VU360 has been updated, discontinue usage of and destroy any media containing MAC VU360 V1.01 SP06 and any prior versions of MAC VU360 software. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 5,284 units
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 Distribution: AUSTRALIA, AUSTRIA, BELGIUM, Canada, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, Germany, Hong Kong, IRELAND, ISRAEL, ITALY, Korea, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, United Kingdom.
Product codes and lots: Model: 2030360 001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0543-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0543-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-07

Product code DPS

K173830Class IIMAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. / cleared 2018-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)