Recall Z-0554-2024 ยท EXS Urinometer, Electrical
C.R. Bard Inc
Sensica Urine Output System, Catalog Number SCCS1002
| Date | Dec 14, 2023 (initiated Nov 15, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 148 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.