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U.S. Department of Health and Human Services

Class 2 Device Recall Advisor

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 Class 2 Device Recall Advisorsee related information
Date Initiated by FirmJanuary 05, 2005
Date PostedFebruary 10, 2005
Recall Status1 Terminated 3 on November 14, 2005
Recall NumberZ-0533-05
Recall Event ID 30811
510(K)NumberK011177 K030407 K982279 
Product Classification Electrocardiograph - Product Code DPS
ProductAdvisor Vital Signs Monitor model 9200, catalog number 92E654325. Item Description 9200 II 3LD/RP/O2/IP/TP/BATT 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.
Code Information serial number 706460001
FEI Number 2183502
Recalling Firm/
Manufacturer		 Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha WI 53186-1856
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionOn 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.
Quantity in Commerce1
DistributionInternationally only.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DPS
510(K)s with Product Code = DPS
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