MAC VU360, Electrocardiograph recallZ-0543-2021 · GE Healthcare, LLC · initiated Oct 27, 2020
Class II Terminated All recalls posted in December 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect patient identification and/or patient demographic errors.
FDA root cause category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-0543-2021
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 27, 2020
- Posted by the FDA
- Dec 7, 2020
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 5,284 units
- Product code
- DPS
- FDA submissions
- K173830
- 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 description
MAC VU360, Electrocardiograph
Code information (models, lots, serial numbers)
Model: 2030360 001
Other devices under the same FDA submission
2 devices cleared under K173830 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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