Z-0534-05

Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II...

Name: Z-0534-05 Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II...
Creator: Smiths Medical PM, Inc.
Published: 2005-01-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-01-05 / Terminated

FDA source

Smiths Medical PM, Inc. began a recall of Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3... on 2005-01-05. The reason FDA records is "An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0534-05
Status: Terminated
Initiated: 2005-01-05
Posted: 2005-02-10
Terminated: 2005-11-14
Recalling firm: Abbott Medical
Product: Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
Product code: DPS Electrocardiograph
Reason for recall: An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading.
FDA root cause: Other
Action: On 12/22/04 distribution of new units was placed on hold and customers were notified to recommend that they do not use the pace detect function. On 12/27/03 an email was sent to customers of the solution. On 12/29/04 a Technical Worksheet describing how to replace a resistor at R8 was emailed to customers. Between 12/29/04 and 01/03/05 kits containing instructions and new resistors were sent to customers to begin reworking of the devices.
Quantity in commerce: 7
Distribution: Internationally only.
Product codes and lots: serial numbers: 706462000, 706462002, 706462003, 706462005, 706462006, 706462007 and 706462009

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)