• 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 Posted February 14, 2013
Recall Status1 Terminated 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 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 HEALTHCARE FINLAND OY
-
-