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

Class 2 Device Recall GE Healthcare, CARESCAPE Monitor B650

  • 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 GE Healthcare, CARESCAPE Monitor B650 see related information
Date Initiated by Firm September 30, 2011
Date Posting Updated February 14, 2013
Recall Status1 Terminated 3 on January 27, 2014
Recall Number Z-0823-2013
Recall Event ID 64242
510(K)Number K102239  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product GE Healthcare, CARESCAPE Monitor B650.

The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Code Information EW11038885HA, SEW11038870HA, SEW11038869HA, SEW11018748HA, SEW10517973HA, SEW10517972HA, SEW10517971HA, SEW10517970HA, SEW10517969HA, SEW10517968HA, SEW10517962HA, SEW10517955HA, SEW10517953HA, SEW10477639HA, SEW10477637HA, SEW10477633HA, SEW10354753HA, SEW10354732HA, SEW10354686HA, SEW10354685HA, SEW10334210HA, SEW10334191HA, SEW11223091HA, SEW11223045HA, SEW11223044HA, SEW11223043HA, SEW11223041HA, SEW11223040HA, SEW11223033HA, SEW11223031HA, SEW11223018HA, SEW11223012HA, SEW11223010HA, SEW11223002HA, SEW11223001HA, SEW11202773HA, SEW11202728HA, SEW11202686HA, SEW11202392HA, SEW11202375HA, SEW11202374HA, SEW11181825HA, SEW11181824HA, SEW11181795HA, SEW11181793HA, SEW11171493HA, SEW11171485HA, SEW11171484HA, SEW11171453HA, SEW11141064HA, SEW11130673HA, SEW11130651HA, SEW11100002HA, SEW11079544HA, SEW11202326HA, SEW11202324HA, SEW11202318HA, SEW11202316HA, SEW11202315HA, SEW11202311HA, SEW11202305HA, SEW11202303HA, SEW11202302HA, SEW11202297HA, SEW11202295HA, SEW11202292HA, SEW11202285HA, SEW11202213HA, SEW11202211HA, SEW11202210HA, SEW11202209HA, SEW11202208HA, SEW11202206HA, SEW11202205HA, SEW11181951HA, SEW11181946HA, SEW11181945HA, SEW11181944HA, SEW11181940HA, SEW11181939HA, SEW11181931HA, SEW11181831HA, SEW11181829HA, SEW11181827HA, SEW11181822HA, SEW11181821HA, SEW11181820HA, SEW11181819HA, SEW11181818HA, SEW11181817HA, SEW11181816HA, SEW11181815HA, SEW11181814HA, SEW11181812HA, SEW11181811HA, SEW11181810HA, SEW11181809HA, SEW11181808HA, SEW11181807HA, SEW11181806HA, SEW11181805HA, SEW11181804HA, SEW11181803HA, SEW11181802HA, SEW11181772HA, SEW11181771HA, SEW11181769HA, SEW11181768HA, SEW11181767HA, SEW11181766HA, SEW11171535HA, SEW11171528HA, SEW11171524HA, SEW11171523HA, SEW11171522HA, SEW11171521HA, SEW11171520HA, SEW11171519HA, SEW11171518HA, SEW11171516HA, SEW11171515HA, SEW11171514HA, SEW11171512HA, SEW11171510HA, SEW11171504HA, SEW11171501HA, SEW11171500HA, SEW11171491HA, SEW11171490HA, SEW11171488HA, SEW11171479HA, SEW11171477HA, SEW11171475HA, SEW11171473HA, SEW11171466HA, SEW11171463HA, SEW11171449HA, SEW11151287HA, SEW11151281HA, SEW11141063HA, SEW11141058HA, SEW11109981HA, SEW11109976HA, SEW11079530HA, SEW11079388HA, SEW11171468HA, SEW11171459HA, SEW10507813HA, SEW10507802HA, SEW10507801HA, SEW10467385HA, SEW10405636HA, SEW10405631HA, SEW10405629HA, SEW10405627HA, SEW10405608HA, SEW10405599HA, SEW10334229HA, SEW10334228HA, SEW11223124HA, SEW11223039HA, SEW11223015HA, SEW11100042HA, SEW11018746HA, SEW11018659HA, SEW11018657HA, SEW11018656HA, SEW11018655HA, SEW10518016HA, SEW10518015HA, SEW10518014HA, SEW10517952HA, SEW10517951HA, SEW10517950HA, SEW10517949HA, SEW10517948HA, SEW10507886HA, SEW10507885HA, SEW10507884HA, SEW10507883HA, SEW10507880HA, SEW10507879HA, SEW10507878HA, SEW10507877HA, SEW10507876HA, SEW10507875HA, SEW11202289HA, SEW11202733HA, SEW11202701HA, SEW11202698HA, SEW11202695HA, SEW11181780HA, SEW11059105HA, SEW11038922HA, SEW11038915HA, SEW11038874HA, SEW11018590HA, SEW11018589HA, SEW10518003HA, SEW10517967HA, SEW10517966HA, SEW10517940HA, SEW10467340HA, SEW11223125HA, SEW11223098HA, SEW11223050HA, SEW11223037HA, SEW11223017HA, SEW11223009HA, SEW11202779HA, SEW11202770HA, SEW11202767HA, SEW11202757HA, SEW11202752HA, SEW11202738HA, SEW11202691HA, SEW11202689HA, SEW11202312HA, SEW11181832HA, SEW11171513HA, SEW11171508HA, SEW11171494HA, SEW11171448HA, SEW11171444HA, SEW11171443HA, SEW11151282HA, SEW11151278HA, SEW11151227HA, SEW11151201HA, SEW11151190HA, SEW11141084HA, SEW11141062HA, SEW11130669HA, SEW11130668HA, SEW11130667HA, SEW11130666HA, SEW11130664HA, SEW11130662HA, SEW11130659HA, SEW11130658HA, SEW11130657HA, SEW11130656HA, SEW11130644HA, SEW11130643HA, SEW11120469HA, SEW11120445HA, SEW11100154HA, SEW11100153HA, SEW11100151HA, SEW11100148HA, SEW11100143HA, SEW11100142HA, SEW11100140HA, SEW11100129HA, SEW11100126HA, SEW11100125HA, SEW11100124HA, SEW11100123HA, SEW11100121HA, SEW11100119HA, SEW11100115HA, SEW11100113HA, SEW11100112HA, SEW11100111HA, SEW11100097HA, SEW11100095HA, SEW11100093
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 has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.
FDA Determined
Cause 2
Software design
Action GE Healthcare sent an Important Product Notification letteron September 30, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to keep the patient under close observation or use an alternate monitoring device. Customers should not disconnect the affected USB devices from the patient monitor during an active patient case. If the license is enabled, the alarm limit adjustments from the iCentral Client has an L-NETM-00 license should be disabled. GE Healthcare would contact customers to schedule the update. Customers with questions should contact Technical Support or their local representative. For questions regarding this recall call 262-513-4122.
Quantity in Commerce 2813
Distribution Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA,IL,IN, IA, KS, KY,LA, MD, MA, MI, M, MO, NE, NE,NJ, NM, NY, NC, OH, OK PA, SC, TN, TX, UT, VA, WI. Internationally to UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, ROMANIA, PORTUGAL, POLAND, PERU, NORWAY, NEW ZEALAND, NETHERLAND, MALAYSIA, LITHUANIA, KUWAIT, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, COLOMBIA, CHILE, CANADA, BELGIUM BAHRAIN, AUSTRIA, AUSTRALIA.
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
-
-