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Advisor Vital Signs Monitor (model 9200), catalog number… recallZ-0230-06 · Smiths Medical PM, Inc. · initiated Sep 1, 2005

Terminated All recalls posted in November 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical PM, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Other

What the company is doing

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.

Recall details

Recall number
Z-0230-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 1, 2005
Posted by the FDA
Nov 30, 2005
Recalling firm
Smiths Medical PM, Inc.
Quantity
4
Product code
DPS
FDA submissions
K010770, K011177, K030407, K982279
Distribution
AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain

Product description

Advisor Vital Signs Monitor (model 9200), catalog number 925474335, 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, standard SPO2 option, Invasive Pressure/Temperature option, printer and battery.

Code information (models, lots, serial numbers)

serial numbers: AM05080008, AM05080009, AM05080010 and AM05080011.

Other devices under the same FDA submission

2 devices cleared under K010770, K011177, K030407, K982279 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 33375).

Sources and updates

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