• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Carescape Patient Data Module v2.0

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 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 511592GA
SA308511598GA
SA308511600GA
SA308511607GA
SA308511611GA
SA308511617GA
SA308511628GA
SA308511631GA
SA308511640GA
SA308511646GA
SA308511709GA
SA309042133GA
SA309122773GA
SA309132856GA
SA309132868GA
SA309142929GA
SA309142930GA
SA309142931GA
SA309142934GA
SA309142939GA
SA309142940GA
SA309183211GA
SA309183222GA
SA309183234GA
SA309183247GA
SA309193253GA
SA309193256GA
SA309304248GA
SA309476921GA
SA309477007GA
SA309517484GA
SA309517692GA
SA309517809GA
SA309517873GA
SA309517905GA
SA309527921GA
SA309527934GA
SA309527942GA
SA311184744GA
SA311236295GA
SA311236322GA
SA311287197GA
SA311297341GA
SA311297366GA
SA312039140GA
SA312070007GA
SA312070009GA
SA312080401GA
SA307221005GA
SA308511465GA
SA308511523GA
SA309517721GA
SA309517777GA
SA309517786GA
SA310028203GA
SA310028211GA
SA310038395GA
SA310393052GA
SA311101398GA
SA311163431GA
SA310529057GA
SA311236028GA
SA311091032GA
SA310507480GA
SA310528949GA
SA3111111558GA
SA308409043GA
SA308419227GA
SA311142758GA
SA311142784GA
SA309193258GA
SA309365229GR
SA309497149GR
SA309517853GR
SA310517610GR
SA310351548GA
SA311256716GA
SA311287117GA
SA311101345GA
SA311195229GA
SA311205318GA
SA307231222GA
SA308135511GA
SA308135569GA
SA308135602GA
SA308327383GA
SA308327458GA
SA308327513GA
SA310455126GA
SA310465305GA
SA310465318GA
SA310517763GA
SA310528992GA
SA311111591GA
SA311142874GA
SA307342328GA
SA307352353GA
SA308419241GA
SA308439453GA
SA311327878GA
SA311163403GA
SA311163985GA
SA309426141GA
SA309426161GA
SA309517629GA
SA311153192GA
SA311297279GA
SA311122211GA
SA311101250GA
SA311101421GA
SA308409069GA
SA311205448GA
SA311184563GA
SA311153032GA
SA310518349GA
SA310518376GA
SA310331218GA
SA310331261GA
SA310507113GA
SA311195195GA
SA311195261GA
SA311163639GA
SA311184454GA
SA311090784GA
SA307210831GA
SA311122176GA
SA310199566GA
SA310199689GA
SA311163873GA
SA311080627GA
SA310361708GA
SA310506654GA
SA310518399GA
SA310539311GA
SA311266883GA
SA310518635GA
SA310528961GA
SA311142707GA
SA307302064GA
SA307453454GA
SA307463649GA
SA308429411GA
SA308429415GA
SA308449620GA
SA308459817GA
SA308459823GA
SA308491072GA
SA308491079GA
SA310260362GA
SA310507038GA
SA310507439GA
SA311060151GA
SA311101113GA
SA311101126GA
SA311101468GA
SA310475485GA
SA310475579GA
SA310475592GA
SA310518230GA
SA310518265GA
SA310518286GA
SA310518304GA
SA311070578GA
SA311080742GA
SA311101071GA
SA311101311GA
SA308084724GA
SA308084791GA
SA308317238GA
SA308337572GA
SA308337596GA
SA308337628GA
SA311069763GA
SA311069774GA
SA311069786GA
SA307453482GA
SA308481060GA
SA308491097GA
SA308501258GA
SA308501262GA
SA308501267GA
SA308511576GA
SA311163916GA
SA309517521GA
SA309517790GA
SA309527919GA
SA309527961GA
SA311205440GA
SA310219837GA
SA310382709GA
SA311142785GA
SA311287128GA
SA311287187GA
SA311287213GA
SA310507521GA
SA311101216GA
SA311091005GA
SA311121820GA
SA310529200GA
SA311111670GA
SA311111682GA
SA311121752GA
SA311121790GA
SA311121801GA
SA311121825GA
SA311121844GA
SA311132372GA
SA311132483GA
SA311132573GA
SA309253833GA
SA309517527GA
SA311246384GA
SA307392834GA
SA307403042GA
SA307423142GA
SA307392934GA
SA307393003GA
SA307403137GA
SA307423181GA
SA308115289GA
SA310518333GA
SA307453528GA
SA307493991GA
SA307493887GA
SA307494033GA
SA307392760GA
SA307443335GA
SA308501339GA
SA308521781GA
SA310496415GA
SA310506784GA
SA307392842GA
SA307443218GA
SA311060143GA
SA311060169GA
SA307403138GA
SA307443315GA
SA308115300GA
SA310518557GA
SA310529090GA
SA309233517GA
SA310382639GA
SA310382714GA
SA310518671GA
SA310507417GA
SA310507481GA
SA310507493GA
SA311070481GA
SA311090898GA
SA311121766GA
SA311121827GA
SA311122001GA
SA311122131GA
SA311153317GA
SA310290714GA
SA311069794GA
SA311069853GA
SA307514308GA
SA307221035GA
SA307221078GA
SA307221131GA
SA307231227GA
SA307332268GA
SA307332286GA
SA307403075GA
SA307403116GA
SA307403136GA
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
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
-
-