Smiths Medical PM, Inc. Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. 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.
Brand
Smiths Medical PM, Inc.
Lot Codes / Batch Numbers
serial numbers: 706330000, 706431000, 706431001, 706431002, 706431003, 706431004, 706431005, 706431006, 706431008, 706431009, 706431010
Products Sold
serial numbers: 706330000, 706431000, 706431001, 706431002, 706431003, 706431004, 706431005, 706431006, 706431008, 706431009, 706431010
Smiths Medical PM, Inc. is recalling Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/ due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026