Device product
MAC VU360, Electrocardiograph
Z-0543-2021
Product summary
- 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
Incorrect patient identification and/or patient demographic errors.