Z-0222-06

Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board...

Name: Z-0222-06 Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board...
Creator: Smiths Medical PM, Inc.
Published: 2005-09-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-09-01 / Terminated

FDA source

Smiths Medical PM, Inc. began a recall of Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed... on 2005-09-01. The reason FDA records is "Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0222-06
Status: Terminated
Initiated: 2005-09-01
Posted: 2005-11-30
Terminated: 2007-06-27
Recalling firm: Abbott Medical
Product: Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) with 3-lead 60 Hz ECG, standard SPO2 option, printer and battery.
Product code: DPS Electrocardiograph
Reason for recall: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.
FDA root cause: Other
Action: Distirbutors and consignees were notified beginning 09/01/05 via email or phone about Safety Action Bulletin 05-004. Customers were asked to respond to Smiths Medical with a written acknowledgement that they received this Safety Action Bulletin (SAB). The SAB described the issue, actions they should take and instruction on how to have the monitor repaired.
Quantity in commerce: 1
Distribution: AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain
Product codes and lots: Serial number: AM05070166

Product code DPS

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)