Recall Z-0554-2024— C.R. Bard Inc
Class II · Ongoing
Class II FDA medical device recall by C.R. Bard Inc, initiated 2023-11-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Sensica Urine Output System, Catalog Number SCCS1002. Reason: BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time..
- Recalling firm
- C.R. Bard Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-15
- Firm location
- Covington, GA, United States
Product description
Sensica Urine Output System, Catalog Number SCCS1002
Reason for recall
BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
Data sourced from openFDA. This site is unofficial and independent of the FDA.