FDA Medical Device Recalls (openFDA)
Smiths Medical PM, Inc.: Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG and standard SPO2 option.
- Recall number
- Z-0226-06
- Recalling firm
- Smiths Medical PM, Inc.
- Product
- Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG and standard SPO2 option.
- Status
- Terminated
- Initiated
- 2005-09-01
- Posted
- 2005-11-30
- Terminated
- 2007-06-27
- Reason
- 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.
- 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
- 1
- Distribution
- AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain
- Lot, serial or model codes
- serial number: AM05070061
- 510(k) numbers
- ["K010770","K011177","K030407","K982279"]
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 2183502
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28