Sensica Urine Output System displays incorrect timestamps when connected to WiFi
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves data integrity failure in a patient monitoring system. Although no deaths, injuries, or illnesses are reported, incorrect timestamp data in a urine output monitoring device constitutes a risk-of-harm product where inaccuracy could impact clinical decision-making. Per the rubric, when injuries are not reported the maximum score is 3.
Plain-English summary
The Sensica Urine Output System, Catalog Number SCCS1002, manufactured by C.R. Bard Inc, is being recalled due to a WiFi connectivity issue that causes incorrect time display and data recording.
When the device is connected to WiFi or internet, the displayed time may change during a patient monitoring session. This causes incorrect times to appear on the monitoring screen, incorrect timestamps in hour block data, incorrect timestamps in data screens, and incorrect catheter use time records.
The recall affects 148 units distributed nationwide in the United States. Affected units are identified by serial numbers listed under UDI/DI 00801741215773. Healthcare providers using affected devices should contact C.R. Bard Inc for guidance on corrective measures.
The recalled product
- Product
- Sensica Urine Output System, Catalog Number SCCS1002
- Manufacturer
- C.R. Bard Inc
- Hazard
- timestamp-error
- data-integrity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00801741215773
- Serial numbers: BMGPRMYS001
- BMGPRMYS003
- BMGPRMYS004
- BMGPRMYS005
- BMGPRMYS006
- BMGPRMYS007
- BMGPRMYS020
- BMGPRMYS026
- BMGPRMYS028
- BMGPRMYS030
- BMFWRMSBT4
- BMFWRMSJ45
- BMFWRMSJ49
- BMFZRMS104
- BMGNRMS085
- BMFSRMSH98
- BMFSRMSJ01
- BMFVRMSQ62
- BMFVRMSQ66
Distribution
Distributed nationwide across the United States.
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