FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: MAC VU360, Electrocardiograph
- Recall number
- Z-0543-2021
- Recalling firm
- GE Healthcare, LLC
- Product
- MAC VU360, Electrocardiograph
- Status
- Terminated
- Initiated
- 2020-10-27
- Posted
- 2020-12-07
- Terminated
- 2024-05-03
- Reason
- Incorrect patient identification and/or patient demographic errors.
- 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
- 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.
- Lot, serial or model codes
- Model: 2030360 001
- 510(k) numbers
- ["K173830"]
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28