Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Advisor

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Advisor see related information
Date Initiated by Firm January 05, 2005
Date Posted February 10, 2005
Recall Status1 Terminated 3 on November 14, 2005
Recall Number Z-0534-05
Recall Event ID 30811
510(K)Number K011177  K982279  K030407  
Product Classification Electrocardiograph - Product Code DPS
Product 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.
Code Information serial numbers: 706462000, 706462002, 706462003, 706462005, 706462006, 706462007 and 706462009
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
Action 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.
Quantity in Commerce 7
Distribution Internationally only.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DPS and Original Applicant = BCI INTL., INC.
510(K)s with Product Code = DPS and Original Applicant = BCI, INC.
-
-