GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-0543-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

MAC VU360, Electrocardiograph

Product Classification:

Class II

Date Initiated: October 27, 2020

Date Posted: December 16, 2020

Recall Number: Z-0543-2021

Event ID: 86725

Reason for Recall:

Incorrect patient identification and/or patient demographic errors.

Status: Terminated

Product Quantity: 5,284 units

Code Information:

Model: 2030360 001

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated