Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2379-2018·Announced 2018-07-18

Smiths Medical Recalls BCI Advisor Vital Signs Monitors Due to Printing Defects

Smiths Medical ASD Inc. is recalling 10 BCI Advisor Vital Signs Monitors because certain printing modes may not function properly.

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, and the defect involves non-functional printing modes rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity issue.

Plain-English summary

Smiths Medical ASD Inc. is recalling 10 units of the BCI Advisor Vital Signs Monitor, Model 9200. The affected devices have reorder numbers 920654235, 920654235A, 920654335A, and 920674235A. These monitors are intended for use in hospital and clinic settings, including ICUs, CCUs, operating rooms, and emergency rooms, but are not intended for home use or as apnea monitors.

The recall was initiated because some printing modes on the devices may not function properly. Specifically, the tabular data printing, real-time continuous printouts, and automatic interrupt print feature may fail to operate as intended. The agency has classified this as a Class II recall.

The affected devices were distributed nationwide in the United States, specifically in Colorado and Montana, as well as to Armenia. Users of these devices should contact Smiths Medical ASD Inc. for further instructions on how to address the printing defects.

The recalled product

Product: BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is…
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Vital Signs Monitor
Hazard: malfunction
Affected units: 10

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 (10)

Reorder number 920654235: Serial numbers 4068892
4068893
4068894
and 4068895
Reorder number 920654235A: Serial number 4061288
Reorder number 920654335A: Serial numbers 4059004
4059005
4068891
and 4069354
Reorder Number 920674235A: 4064435

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Smiths Medical ASD Inc.

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