Smiths Medical Recalls BCI Advisor Vital Signs Monitors for Data Errors
Smiths Medical is recalling 15 BCI Advisor Vital Signs Monitors because their auxiliary serial ports may transmit incorrect data to collection systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves data integrity issues rather than direct physical injury, and no illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 15 units of the BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. The recall was initiated because the Auxiliary Serial Input/Output Modes on the devices do not function as expected. This malfunction results in data formatting issues or the transmission of incorrect data into or out of the serial port when connected to a data collection system.
The affected devices are distributed in Minnesota. The recall includes five original units with serial numbers 4059587 through 4059591, and an update on April 20, 2015, added ten additional units with serial numbers 4059949, 4059950, 4059951, 4059952, 4059953, 4059954, 4059955, 4059957, 4059958, and 4059960.
The U.S. Food and Drug Administration has classified this as a Class II recall. Users should check their device serial numbers against the list provided and contact Smiths Medical ASD, Inc. for instructions on how to proceed.
The recalled product
- Product
- Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
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 (8)
- 4059950
- 4059951
- 4059952
- 4059953
- 4059954
- 4059955
- 4059957
- 4059958 and 4059960
Distribution
Distributed in 1 state:
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