FDA recall Z-2060-2019

Product

MAC VU360, Model Number 2030360-001, Electrocardiograph

Reason for recall

Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.

Distribution

Worldwide

Key facts

Status

Terminated

Initiation date

2019-06-28

Report date

2019-07-31

Termination date

2021-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2060-2019