Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/SO/O2/IP/TP BMDD. 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.
- Company
- Smiths Medical Pm, Inc.
- Recall Initiated
- January 5, 2005
- Posted
- February 10, 2005
- Terminated
- November 14, 2005
- Recall Number
- Z-0535-05
- Quantity
- 4
- Firm Location
- Waukesha, WI
Reason for Recall
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.
Distribution
Internationally only.
Lot / Code Info
serial numbers: 706475000, 706475001, 7064750002 and 706475003
Root Cause
Other
Action Taken
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.
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