Class 2 Device Recall COROMETIRICS

• Date Initiated by Firm: May 21, 2003
• Date Posted: September 23, 2003
• Recall Status: Terminated on October 27, 2003
• Recall Number: Z-1291-03
• Recall Event ID: 26452
• 510(K)Number: K021135
• Product Classification: System, Monitoring, Perinatal - Product Code HGM
• Product: GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
• Code Information: All serial numbers are involved.
• FEI Number: 1030184
• Recalling Firm/ Manufacturer: GE Medical Systems Information Technologies; 4502 Woodland Corporate Blvd.; Tampa FL 33614
• For Additional Information Contact: Erik Granby; 800-237-2033
• Manufacturer Reason for Recall: The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
• FDA Determined Cause: Other
• Action: The firm mailed or faxed a recall letter to consignees on May 14, 2003 followed by a phone call to each account within two weeks to arrange for a service technician visit to correct the monitors. The recall letter warned the hospitals of the problem and a work around.
• Quantity in Commerce: 170
• Distribution: The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.
• 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 = HGM