MAC VU360, Model Number 2030360-001, Electrocardiograph
Reported: July 31, 2019 Initiated: June 28, 2019 #Z-2060-2019
Product Description
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 369 units
- Distribution
- Worldwide
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
MAC VU360, Model Number 2030360-001, Electrocardiograph. Recalled by GE Healthcare, LLC. Units affected: 369 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2060-2019.
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