Sensica Urine Output System, Catalog Number SCCS1002

FDA device recall Z-0554-2024 · posted 2023-12-14 · Open, Classified

Recall details

Recalling firm

C.R. Bard Inc

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.

Action taken

BD (CR Bard) issued an URGENT Medical Device Product Advisory to its consignees on 11/15/2023, via FedEx and email. The notice explained the problem with the device, potential hazard, and requested that the consignee perform Operating System and Sensica Software settings changes per the instructions provided on all devices within your facility s control using the attached directions.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

EXS

Quantity affected

148 units

Distribution

US Nationwide distribution.

Date initiated

2023-11-15

Date posted

2023-12-14

Location

Covington, GA