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Recall Observatory FDA recall evidence

Device product

MAC VU360, Electrocardiograph

Z-0543-2021

October 27, 2020

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 86725
Status
Terminated
Classification
Class II
Quantity
5,284 units
Official record key
device-enforcement:Z-0543-2021

Official wording

Reason: Incorrect patient identification and/or patient demographic errors.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect patient identification and/or patient demographic errors.