FDA Devices recall · Reported July 18, 2018
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 intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 l
Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).
Smiths Medical Asd Inc. recalled BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654… - a moderate-severity action.
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654… was recalled by Smiths Medical Asd Inc. in July 18, 2018. Reason: Some printing modes on the devices may not function properly (tabular data printing, real-time continuous pri…. Check the official notice for the remedy. Verify recall #Z-2379-2018 with the FDA Devices before acting.
The recall
Smiths Medical Asd Inc. issued this moderate-severity FDA Devices recall-Some printing modes on the devices may not function properly (tabular data printing, real-time continuous pri….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- July 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2379-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead/5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
Reason for recall
Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2379-2018 |
| Date reported | July 18, 2018 |
| Date initiated | November 29, 2017 |
| Recalling firm | Smiths Medical Asd Inc. |
| Firm location | Minneapolis, MN |
| Affected scope | 10 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of CO and MT. Foreign distribution was to Armenia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2379-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026