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U.S. Department of Health and Human Services

Class 2 Device Recall Carescape Patient Data Module v2.0

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 Class 2 Device Recall Carescape Patient Data Module v2.0 see related information
Date Posted December 14, 2012
Recall Status1 Terminated on December 03, 2013
Recall Number Z-0524-2013
Recall Event ID 63655
510(K)Number K071073 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
Code Information
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
FDA Determined
Cause 2
Software design
Action Consignees were sent on 2/17/2012 three GE Healthcare "Important Product Information" letters dated 10/17/ 2011. The letters were addressed to Healthcare Administrator/Risk Manager, Director of Biomedical Engineering, and Chief of Nursing. The letters described the Issue, Instructions, Affected Product Details, Product Correction and Contact Information.
Quantity in Commerce 10,250
Distribution Worldwide distribution, including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, LA, KS, KY, LA, ME,MD, MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN,TX, UT,VA, WA, WT, WY and the countries of the UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAK IA, SINGAPORE, SAUDI ARABIA, QATAR, POLAND, PERU, PANAMA, NORWAY, NEW ZEALAND, NETHERLAND, MEXICO, MALAYSIA, LEBANON, KUWAIT, KOREA, JAPAN, ITALY, INDONESIA, INDIA, IRELAND, GERMANY FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHILE CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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