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Advisor Vital Signs Monitor model 9200, catalog number… recallZ-0531-05 · Smiths Medical PM, Inc. · initiated Jan 5, 2005

Terminated All recalls posted in February 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

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 category: Other

What the company is doing

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.

Recall details

Recall number
Z-0531-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 5, 2005
Posted by the FDA
Feb 10, 2005
Recalling firm
Smiths Medical PM, Inc.
Quantity
11
Product code
DPS
FDA submissions
K030407, K982279, K011177
Distribution
Internationally only.

Product description

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.

Code information (models, lots, serial numbers)

serial numbers: 706330000, 706431000, 706431001, 706431002, 706431003, 706431004, 706431005, 706431006, 706431008, 706431009, 706431010

Other devices under the same FDA submission

2 devices cleared under K030407, K982279, K011177 — 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 30811).

Sources and updates

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