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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).

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  Class 2 Device Recall GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). see related information
Date Initiated by Firm May 04, 2015
Date Posted May 12, 2015
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-1606-2015
Recall Event ID 71211
510(K)Number K131223  K131414  K092027  K102239  K132533  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Code Information Mfg Lot or Serial # SED12394685GA SED12394688GA SED12404710GA SED12404711GA SED12404713GA SED12404716GA SED12404718GA SED12404720GA SED12404721GA SED12404722GA SED12404723GA SED12404725GA SED12445258GA SED12445259GA SED12445261GA SED12445262GA SED12445264GA SED12445265GA SED12445266GA SED12445268GA SED12445269GA SED12445298GA SED12445299GA SED12445309GA SEW12265533HA SEW13286489HA SEW14095097HA SEW14095105HA SEW14105496HA SEW14105497HA SEW14105502HA SEW14105503HA SEW14160623HA SEW14160626HA SEW14171213HA SEW14171313HA SEW14171314HA SEW14171315HA SEW14171317HA SEW14171319HA SEW14171320HA SEW14171321HA SKA14062508GA SKA14062511GA SKA14284377GA SKA14284378GA SKA14284382GA SKA14284385GA SKA14284388GA SKA14284393GA SKA14284394GA SKA14284395GA SKA14365356GA SKA14365375GA SKA14365378GA SKA14365380GA SKA14365382GA SKA14487159GA SKA14487160GA SKA14487161GA SKA14487162GA SKA14487163GA SKA14487165GA SKA14487166GA SKA14487168GA SKA14487170GA SKA14487171GA SKA14487172GA SKA14487173GA SKA14487174GA SKA14487175GA SKA14487176GA SKA14487178GA SKA14487180GA SKA14487182GA SKA14487185GA SKA14487218GA SKA15038500GA SKA15048558GA SMV15123913HA SMV15145547HA SMV15145548HA SMV15124159HA SEW12018091HA SKA13390428GA SKA13390435GA SKA13390440GA SKA13390468GA SKA13390474GA SKA13430502GA SKA13430503GA SKA13430504GA SKA13430505GA SMV15123911HA SED11067045GA SED12394559GA SKA14092755GA SMV15123912HA SED11229605GA SED11239640GA SED11239644GA SED11239645GA SED11239663GA SED11239664GA SED11239668GA SED11239669GA SED11239678GA SED11239679GA SED11239680GA SMV15123915HA 
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patient¿s condition and delayed or missed life sustaining patient treatment
FDA Determined
Cause 2		 Software design
Action GE Healthcare sent an Urgent Medical Device Correction letter dated May 1, 2015, to all affected consignees. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 110 (83 units US, 27 units OUS)
Distribution Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.
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 HEALTHCARE FINLAND OY
510(K)s with Product Code = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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