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U.S. Department of Health and Human Services

Class 2 Device Recall COROMETIRICS

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  Class 2 Device Recall COROMETIRICS see related information
Date Initiated by Firm May 21, 2003
Date Posted September 23, 2003
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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