Class 2 Device Recall ApexPro FH Telemetry System

• Date Initiated by Firm: June 23, 2006
• Date Posted: October 21, 2006
• Recall Status: Terminated 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.
• FEI Number: 3005860720
• 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: 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