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

Class 2 Device Recall CARESCAPE Monitor B850

  • 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 Monitor B850 see related information
Date Posted June 21, 2013
Recall Status1 Terminated on June 30, 2014
Recall Number Z-1567-2013
Recall Event ID 65379
510(K)Number K092027 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product CARESCAPE Monitor B850

Product Usage:
The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.
Code Information 28GA
SED10495333GA
SED10495334GA
SED10505352GA
SED10505368GA
SED10505398GA
SED10505399GA
SED10505426GA
SED10505433GA
SED10505437GA
SED10505438GA
SED10505439GA
SED10505440GA
SED10505441GA
SED10505442GA
SED10505461GA
SED10505462GA
SED10505469GA
SED10505470GA
SED10505474GA
SED10505478GA
SED10505485GA
SED10515829GA
SED10515876GA
SED10526200GA
SED10526210GA
SED10526198GA
SED10526207GA
SED10273049GA
SED10273062GA
SED10283073GA
SED11380702GA
SED11380733GA
SED11380734GA
SED11400743GA
SED11400744GA
SED11400747GA
SED11400752GA
SED11400753GA
SED11400754GA
SED11400755GA
SED11400756GA
SED11400763GA
SED11400764GA
SED11400765GA
SED11400766GA
SED11400767GA
SED11400768GA
SED11400769GA
SED11400770GA
SED11400771GA
SED11400772GA
SED11400773GA
SED11400774GA
SED11400775GA
SED11400776GA
SED11400777GA
SED11400778GA
SED11400779GA
SED11400780GA
SED11400781GA
SED11400782GA
SED11400783GA
SED11400784GA
SED11400785GA
SED11400786GA
SED11400787GA
SED11400788GA
SED11400789GA
SED11400790GA
SED11400791GA
SED11400792GA
SED11400793GA
SED11400794GA
SED11400795GA
SED11400796GA
SED11400797GA
SED11400798GA
SED11400799GA
SED11400800GA
SED11400801GA
SED11400802GA
SED11400803GA
SED11400804GA
SED11400805GA
SED11400806GA
SED11400807GA
SED11400808GA
SED11400809GA
SED11400810GA
SED11400811GA
SED11400812GA
SED11400813GA
SED11400814GA
SED11400815GA
SED11400816GA
SED11400817GA
SED11400818GA
SED11400819GA
SED11400820GA
SED11400821GA
SED11400822GA
SED11400823GA
SED11400824GA
SED11400825GA
SED11400826GA
SED11400827GA
SED11400828GA
SED11400829GA
SED11410838GA
SED11410839GA
SED11410840GA
SED11410841GA
SED11410842GA
SED11410843GA
SED11410844GA
SED11410845GA
SED11410856GA
SED11410857GA
SED11410858GA
SED11410859GA
SED11410861GA
SED11410862GA
SED11420887GA
SED11107655GA
SED09030233GP
SED09030234GP
SED09030235GP
SED09030236GP
SED09030237GP
SED09030238GP
SED09030239GP
SED09030240GP
SED09050242GP
SED09050243GP
SED09050244GP
SED09090250GP
SED09090251GP
SED09090252GP
SED09130285GP
SED09130300GP
SED09330580GA
SED09330590GA
SED09340610GA
SED09390859GA
SED09421003GA
SED09421008GA
SED07510001GP
SED07510002GP
SED07510003GP
SED07510004GP
SED07510005GP
SED07510006GP
SED07510007GP
SED07510008GP
SED07510009GP
SED07510010GP
SED07510011GP
SED07510012GP
SED07510013GP
SED07510014GP
SED07510015GP
SED07510016GP
SED07510017GP
SED07510018GP
SED07510019GP
SED07510020GP
SED07510021GP
SED07510022GP
SED07510023GP
SED07510024GP
SED07510025GP
SED07510026GP
SED07510027GP
SED07510028GP
SED07510029GP
SED07510030GP
SED07510031GP
SED07510032GP
SED07510033GP
SED07510034GP
SED07510035GP
SED07510036GP
SED07510037GP
SED07510038GP
SED07510039GP
SED07510040GP
SED07510041GP
SED07510042GP
SED08060045GP
SED08060046GP
SED08060047GP
SED08060048GP
SED08060049GP
SED08060050GP
SED08060051GP
SED08060052GP
SED08060053GP
SED08060054GP
SED08060055GP
SED08060056GP
SED08060057GP
SED08060058GP
SED08060059GP
SED08060060GP
SED08060061GP
SED08060062GP
SED08060063GP
SED08060064GP
SED08060065GP
SED08060066GP
SED08060067GP
SED08060068GP
SED08060069GP
SED08060070GP
SED08060071GP
SED08060072GP
SED08070073GP
SED08070074GP
SED08070075GP
SED08070076GP
SED08070077GP
SED08080078GP
SED08080079GP
SED08080080GP
SED08080081GP
SED08080082GP
SED08080083GP
SED08080084GP
SED08080085GP
SED08080086GP
SED08080087GP
SED08080088GP
SED08080089GP
SED08080090GP
SED08080091GP
SED08080092GP
SED08080093GP
SED08080094GP
SED08080095GP
SED08080096GP
SED08080097GP
SED08080098GP
SED08080099GP
SED08080100GP
SED08080101GP
SED08080102GP
SED08080103GP
SED08080104GP
SED08080105GP
SED08080106GP
SED08080107GP
SED08080108GP
SED08080109GP
SED08080110GP
SED08080111GP
SED08080112GP
SED08140113GP
SED08140114GP
SED08140115GP
SED08140116GP
SED08140117GP
SED08140118GP
SED08140119GP
SED08140120GP
SED08150123GP
SED08150124GP
SED0
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 become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.
FDA Determined
Cause 2
Software design
Action GE Healthcare sent "Important Product Information" letter dated 12 July 2012 to all affected customers. The letter described the Subject (issues) , Instructions, Affected Product Details, Product Correction and actions to be taken. For questions contact Technical Support 1-800-558-7044 or your local Service Representative.
Quantity in Commerce 12,779
Distribution Worldwide Distribution - USA Nationwide including the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, IA, ME, MD,MA, MI, MN, MS, MO, MT, NE,NV,NH, NJ, NM, NY, NC, OR, OK OH, PA, PR, SC, TN, TX, UT, VA, WA, WY, WI, WY, and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK,, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLAND, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
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
-
-