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U.S. Department of Health and Human Services

Class 2 Device Recall ApexPro FH Telemetry System

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  Class 2 Device Recall ApexPro FH Telemetry System see related information
Date Initiated by Firm June 23, 2006
Date Posted October 21, 2006
Recall Status1 Terminated 3 on May 25, 2007
Recall Number Z-0054-2007
Recall Event ID 35826
510(K)Number K033365  
Product Classification Telemetry System - Product Code MHX
Product ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.
Code Information Software versions v3.8 and earlier.
Recalling Firm/
Manufacturer		 Ge Healthcare
9900 W Innovation Dr
Wauwatosa WI 53226-4856
For Additional Information Contact
800-558-7044 Ext. 2
Manufacturer Reason
for Recall		 System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC does not occur.
FDA Determined
Cause 2		 Other
Action An Urgent Medical Device Correction letter, dated June 23, 2006, was sent to customers notifying them of the issue, provided short term recommendations and provided the long term solution as a software upgrade that will correct this situation. A reply card is asked to be returned to initiate the upgrade process.
Quantity in Commerce 379
Distribution Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.
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 = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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