Z-1692-2015Class II

Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A

Name: Z-1692-2015 Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A
Creator: Smiths Medical ASD, Inc.
Published: 2015-03-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-03-21 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A on 2015-03-21. FDA classified it as Class II and gives the reason as "The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1692-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-21
Posted: 2015-05-29
Terminated: 2015-11-20
Recalling firm: Abbott Medical
Product: Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignee was sent on 3/20/2015 a Smiths Medical "Urgent Medical Device Recall" letter dated 13 March 2015. The letter was addressed to Supplier Quality. The letter described the issue and the product affected by the recall. Requested consignees to quarantine the affected product and to complete and return the Confirmation Form by Fax to 1-800-237-8033 or by email to [email protected] within 10 days of receipt of this letter. Customers shall report any issues with these products to Smiths Medical's Global Complaint Department at 1-866-216-8806 or [email protected]. For questions they can contact Smiths Medical's Customer Service Department at 1-800-258-5361. UPDATE 4-20-2015 Smiths Medical sent an Urgent Medical Device Recall letter via email to the one consignee on April 10, 2015. The letter identified the additional monitors and requested that those devices be quarantined, return the attached confirmation form, and a customer service representative will contact the consignee to arrange for exchange of the affected Advisor monitors for credit or replacement.
Quantity in commerce: 5 UPDATE 4-20-2015 to include 10 additional devices
Distribution: MN
Product codes and lots: Serial Numbers: 4059587 through 4059591 UPDATED 4-20-2015: additional devices affected have serial numbers: 4059949, 4059950, 4059951, 4059952, 4059953, 4059954, 4059955, 4059957, 4059958 and 4059960

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1692-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1692-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-05-29

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)