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U.S. Department of Health and Human Services

Class 2 Device Recall CARESCAPE Monitor B850

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  Class 2 Device Recall CARESCAPE Monitor B850 see related information
Date Initiated by Firm July 20, 2012
Date Posting Updated June 21, 2013
Recall Status1 Terminated 3 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 15835GA, SED10515854GA, SED10515862GA, SED10515863GA, SED10515864GA, SED10515865GA, SED10515891GA, SED10515892GA, SED10515893GA, SED10515895GA, SED10515896GA, SED10515899GA, SED10515900GA, SED10515901GA, SED10515904GA, SED10515906GA, SED10515908GA, SED10515909GA, SED10515910GA, SED10515911GA, SED10515914GA, SED10515916GA, SED10515918GA, SED10515920GA, SED10515971GA, SED10515973GA, SED10515978GA, SED10516000GA, SED10516004GA, SED09340649GA, SED09431073GA, SED09441079GA, SED09451365GA, SED10102109GA, SED10102111GA, SED10102113GA, SED10102117GA, SED10102119GA, SED10333610GA, SED10333611GA, SED10333614GA, SED10333615GA, SED10333616GA, SED10384055GA, SED10384056GA, SED10384057GA, SED10384104GA, SED10384105GA, SED10384106GA, SED10424385GA, SED10424389GA, SED10424392GA, SED10424393GA, SED10424394GA, SED10424485GA, SED10424503GA, SED10434593GA, SED10515890GA, SED10515974GA, SED10515987GA, SED10516096GA, SED10516099GA, SED10526127GA, SED10526131GA, SED10526132GA, SED10526164GA, SED10526144GA, SED10526188GA, SED10526195GA, SED10526205GA, SED10526206GA, SED10526230GA, SED10212789GA, SED10515816GA, SED11046815GA, SED11026551GA, SED11026561GA, SED10536529GA, SED10536528GA, SED10536524GA, SED10536518GA, SED11026541GA, SED11026543GA, SED10536507GA, SED10424507GA, SED10516011GA, SED10293142GA, SED10293178GA, SED10293188GA, SED10293189GA, SED10293190GA, SED10293193GA, SED10516097GA, SED10526145GA, SED10515745GA, SED10363875GA, SED10363897GA, SED10363908GA, SED10363912GA, SED10373919GA, SED09441214GA, SED10333612GA, SED10333613GA, SED10424386GA, SED10424388GA, SED10424390GA, SED10424391GA, SED10424395GA, SED10424396GA, SED10424506GA, SED10434629GA, SED10516073GA, SED10526163GA, SED11077184GA, SED10384166GA, SED10384164GA, SED10505408GA, SED10516074GA, SED10516075GA, SED10516076GA, SED10516077GA, SED10516078GA, SED10516079GA, SED11057058GA, SED11067036GA, SED11067073GA, SED11067077GA, SED11077169GA, SED11077196GA, SED11077211GA, SED11077212GA, SED11077221GA, SED11077234GA, SED11077236GA, SED11077241GA, SED11077244GA, SED11077249GA, SED11077253GA, SED11077255GA, SED11087258GA, SED11087259GA, SED11087260GA, SED11087261GA, SED11087262GA, SED11087265GA, SED11087272GA, SED11087385GA, SED11087387GA, SED11097477GA, SED105158900A, SED10485132GA, SED10516064GA, SED11077178GA, SED11077157GA, SED11077149GA, SED11077148GA, SED11077168GA, SED11077217GA, SED11077208GA, SED11046723GA, SED11046751GA, SED11046772GA, SED11046801GA, SED11046802GA, SED11046804GA, SED11046811GA, SED11046843GA, SED11046844GA, SED11046846GA, SED11046847GA, SED11046849GA, SED11046860GA, SED11046861GA, SED11046862GA, SED11046863GA, SED11046866GA, SED11046867GA, SED11046873GA, SED11056894GA, SED10082001GA, SED10102100GA, SED10082002GA, SED10041835GA, SED10192723GA, SED10192725GA, SED10192726GA, SED10192728GA, SED10192729GA, SED10192730GA, SED10192731GA, SED10464924GA, SED10485111GA, SED10485115GA, SED10485117GA, SED10485118GA, SED10485119GA, SED10485122GA, SED10485123GA, SED10485125GA, SED10485126GA, SED10485130GA, SED10485131GA, SED010464924GA, SED010485111GA, SED010485115GA, SED010485117GA, SED010485118GA, SED010485119GA, SED010485122GA, SED010485123GA, SED010485124GA, SED010485125GA, SED010485126GA, SED010485130GA, SED010485131GA, SED10485124GA, SED10516082GA, SED10394180GA, SED10262949GA, SED10262950GA, SED10252912GA, SED10262966GA, SED10262963GA, SED10262964GA, SED10262969GA, SED10262958GA, SED11056937GA, SED11056938GA, SED11056946GA, SED11056955GA, SED10323580GA, SED10323581GA, SED10323582GA, SED10323583GA, SED10323584GA, SED10323585GA, SED10323586GA, SED10323587GA, SED10454740GA, SED09280414GA, SED10212786GA, SED10212787GA, SED10212788GA, SED11097476GA, SED10102104GA, SED10102101GA, SED10192724GA, SED10192727GA, SED10192732GA, SED11067109GA, SED10132501GA, SED10142562GA, SED10142569GA, SED10142570GA, SED10222868GA, SED10363869GA, SED010485136GA, SED11036623GA, SED10485135GA, SED10485137GA, SED010485135GA, SED010485137GA, SED11036597GA, SED11036598GA, SED11036600GA, SED11036601GA.
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 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 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 = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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