Z-2379-2018Class II

BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and...

Name: Z-2379-2018 BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and...
Creator: Smiths Medical ASD Inc.
Published: 2017-11-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-11-29 / Terminated / root cause: software

FDA source

Smiths Medical ASD Inc. began a recall of BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to... on 2017-11-29. FDA classified it as Class II and gives the reason as "Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2379-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Posted: 2018-07-06
Terminated: 2018-07-11
Recalling firm: Abbott Medical
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 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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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).
Root cause tag: software
FDA root cause: Software design
Action: Smiths Medical sent an Urgent Medical Device Letters dated 11/29/2017 via FedEx tracked mailing. The letter identified the affected product, problem and actions to be taken. For questions call Smith Medical Customer Service at 1-800-258-5361.
Quantity in commerce: 10 devices
Distribution: Worldwide Distribution - US Nationwide in the states of CO and MT. Foreign distribution was to Armenia.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2379-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2379-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-06

Product code CCK

K030407Class IIAdvisor, Model 9200Bci, Inc. / cleared 2003-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)