Advisor Vital Signs Monitor (model 9200), catalog number 925654335, 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 60 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature option, printer and battery.
FDA Recall Z-0233-06 · Posted 2005-11-30
Advertisement
Recalling FirmSmiths Medical PM, Inc.
Recall StatusTerminated
Product CodeDPS
Date Initiated2005-09-01
Date Terminated2007-06-27
Product Quantity5
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.
Firm 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.
Root Cause
Other
Distribution Pattern
AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement