Vios Monitoring System Bedside Monitor Model BSM2050
Murata Vios, Inc. · Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectiv…
Open FDA's page for this record- Cfres ID
- 212419
- Product res number
- Z-1292-2025
- Event date initiated
- 2024-08-09
- Event date posted
- 2025-03-06
- Recall status
- Open, Classified
- Res event number
- 96252
- Product code
- DRT
- Product description
- Vios Monitoring System Bedside Monitor Model BSM2050
- Code info
- 1.56.01 UDI: +B595BSM20500/$$7V1.56.01/16D20230630S 1.57.20 UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y Software Versions 1.56.01 and 1.57.20
- Firm FEI number
- 3015328411
- Recalling firm
- Murata Vios, Inc.
- Address 1
- 700 Commerce Dr Ste 190 700 Commerce Dr
- Address 2
- Ste 190
- City
- Woodbury
- State
- MN
- Postal code
- 55125-9239
- Additional info contact
- Customer Service Team 651-764-8467
- Root cause description
- Labeling design
- Product quantity
- 50
- Distribution pattern
- US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.
- Reason for recall
Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
- Action
The firm sent a single page of instructions to customers on August 9, 2024 via email. Customers were informed that tablets should remain plugged into a wall outlet when the tablet is not in use. The tablet battery should not be allowed to fully deplete at any time during patient monitoring or when not in use.
- K numbers
- K172586
- Harmonized identifiers (openFDA)
- Device name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2300
- Device class
- 2
- K number
- K902652, K801761, K761076, K863494, K840525, K851335, K802204, K944262, K842236, K813444, K832131, K910870, K790454, K830795, K151781, K915624, K844911, K842462, K821942, K926298, K883069, K110987, K901031, K202464, K820540, K840521, K841499, K840524, K844348, K820671, K892794, K832018, K821368, K822692, K972789, K832021, K981378, K790552, K831752, K851916 +301 more
- Registration number
- 3003263092, 3015282442, 3008729547, 1319390, 3008716327, 3010703925, 3003589956, 9611031, 3009499478, 3016852448, 1054713, 3007048291, 3016592682, 3010390468, 3016674095, 3015181391, 3014541700, 3009156722, 3007413079, 3016618143, 3012359877, 3013679558, 9710654, 3013826848, 3026751377, 3014848734, 3004977335, 9610816, 2221819, 3010698831, 3003971136, 3004415095, 3008483389, 2080783, 3003800159, 3007305624, 3007603826, 3005521864, 1527715, 3000126629 +64 more
- FEI number
- 3003263092, 3015282442, 3008729547, 1319390, 3008716327, 3010703925, 3003589956, 3009499478, 3016852448, 3007048291, 3016592682, 3010390468, 3000957797, 3016674095, 3015181391, 3014541700, 3009156722, 3007413079, 3016618143, 3012359877, 3013679558, 3013826848, 3026751377, 3014848734, 3004977335, 2221819, 3010698831, 3003971136, 3000215024, 3004415095, 3008483389, 3002807739, 2080783, 3003800159, 3007305624, 3007603826, 3005521864, 1527715, 3000126629, 3002807720 +64 more