Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. 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.
This recall has been terminated (originally issued February 10, 2005).
- Company
- Smiths Medical Pm, Inc.
- Recall Initiated
- January 5, 2005
- Posted
- February 10, 2005
- Terminated
- November 14, 2005
- Recall Number
- Z-0534-05
- Quantity
- 7
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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: 706462000, 706462002, 706462003, 706462005, 706462006, 706462007 and 706462009
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.