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U.S. Department of Health and Human Services

Class 2 Device Recall TRAM module

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  Class 2 Device Recall TRAM module see related information
Date Initiated by Firm December 05, 2013
Date Posted January 22, 2014
Recall Status1 Terminated 3 on July 25, 2016
Recall Number Z-0808-2014
Recall Event ID 67085
510(K)Number K053121  K900540  K011000  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another.
K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. K053121: The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.
Code Information Serial Number C7HA1686G C7HA1700G C7HA1701G C7HA1696G C7HA1692G C7HA1688G C7HA1691G C7HA1689G C7HA1687G C7HA1702G B7HA1657G C7HA1683G C7HA1703G C7HA1707G C7HA1709G C7HA1711G D8HA3141G D8HA3154G D8HA3135G D8HA3136G D8HA3149G D8HA3148G D8HA3128G D8HA3134G D8HA3152G D8HA3140G D8HA3137G D8HA3144G H3S20070G H3S20072G J3S20073G J3S20075G J3S20078G J3S20084G J3S20089G J3S20090G J3S20093G J3S20085G A4S20482G A4S20471G G4S21111G G4S21108G G4S21112G G4S21090G G4S21106G F5HB0489G E5HB0418G F5HB0493G F5HB0491G F5HB0468G F5HB0497G F5HB0478G E5HB0459G C5HB0346G B5HB0261G A6HB0980G A6HB0978G D6HB1379G K7HB4546G K7HB4542G K7HB4552G K7HB4553G K7HB4547G K7HB4556G C8HB5556G C8HB5743G C8HB5744G C8HB5758G C8HB5747G C8HB5746G C8HB5750G C8HB5756G C8HB5757G C8HB5676G D8HB5922G G8HB6864G G8HB6859G B9HA4387G B9HA4403G B9HA4405G B9HA4402G F8HB6464G L4HB0063G L4HB0068G L4HB0064G M4HB0151G M4HB0143G A5HA0120G A5HA0118G A5HA0125G A5HA0122G A5HA0112G A5HA0117G A5HA0111G A5HA0119G A5HA0109G A5HA0114G A5HA0124G L4HC0003G H5HA0362G H5HA0367G D6HB1475G D6HB1467G D6HB1455G D6HB1458G D6HB1442G D6HB1469G D6HB1430G D6HB1465G D6HB1435G D6HB1476G D6HB1440G D6HB1463G D6HB1439G D6HB1438G D6HB1461G D6HB1460G M6HD8751F M6HD8723F M6HD8732F M6HD8683F M6HD8749F M6HD8725F M6HD8748F M6HD8728F M6HD8737F M6HD8730F M6HD8750F M6HD8726F M6HD8747F M6HD8724F M6HD8736F M6HD8744F M6HD8740F M6HD8731F M6HD8745F M6HD8722F M6HD8739F M6HD8741F M6HD8742F M6HD8738F M6HD8746F A7HA1527G A7HA1564G A7HA1550G A7HA1546G A7HA1562G A7HA1529G A7HA1561G A7HA1563G A7HA1560G B7HA1598G B7HA1595G B7HA1583G B7HA1579G B7HA1591G B7HB2686G B7HB2694G B7HB2676G F7HB3564G F7HB3571G F7HB3561G F7HB3567G F7HB3499G F7HB3498G F7HB3526G F7HB3511G F7HB3516G F7HB3536G F7HB3537G F7HB3538G F7HB3541G F7HB3534G F7HB3533G F7HB3539G F7HB3532G F7HB3535G F7HB3548G F7HB3540G F7HB3589G F7HB3556G G7HB3740G G7HB3773G G7HB3772G G7HB3774G G7HB3747G G7HB3769G G7HB3775G G7HB3748G G7HB3766G G7HB3746G G7HB3735G G7HB3741G G7HB3726G H7HB4010G C8HB5492G C8HB5488G C8HB5481G C8HB5480G C8HB5493G C8HB5476G C8HB5508G C8HB5485G C8HB5482G C8HB5449G C8HB5484G C8HB5475G C8HB5490G C8HB5512G C8HB5491G C8HB5474G C8HB5453G C8HB5459G C8HB5456G M8HB8682G M8HB8677G A9HB8818G A9HB8832G M8HB8756G A9HB8806G A9HB8802G A9HB8824G A9HB8817G A9HB8809G M8HC0420G M8HC0427G M8HC0413G M8HC0422G M8HC0430G M8HC0414G M8HC0419G M8HC0416G M8HC0424G M8HC0417G M8HC0418G M8HC0423G M8HC0425G M8HC0415G M8HC0421G M8HC0428G M8HC0426G A9HC0432G A9HC0433G A9HC0436G A9HC0435G A9HC0446G A9HC0439G A9HC0451G A9HC0437G A9HC0440G A9HC0434G A9HC0447G A9HC0444G C9HB9411G C9HB9415G C9HB9445G C9HB9419G C9HB9298G C9HB9323G B9HB9240G C9HB9549G C9HB9563G C9HB9326G C9HB9322G C9HB9366G C9HB9439G C9HB9452G C9HB9451G C9HB9447G C9HB9450G C9HB9530G A8HB5120G RT405523022GA SBB06251137GA D2TW2498G RTW07332120GA L2T14637G A2TW1861G J2T14014G SBB06523641GA D3T42441G A4T19101G RT105433210GA K1T10362G M1TW1346G SBT06180805GA RT106044903GA RT106044763GA RT410139269GA SBB11440867GA SBB09488690GA A0HD3119F E0HD3395F E0HD3397F K0HD3752F K0HD3759F K0HD3762F K1HD4284F K1HD4291F E8HA3281GR M8HA4222GR G9HA5212G F9HA5071G F9HA5059G F9HA5134G C9HA4702G F9HA5131G G9HA5268G G9HA5265G G9HA5262G F9HA5145G K9HB1855G K0HA7181G K0HA7178G K0HA7182G K0HA7189G K0HA7173G K0HA7167G J0HA7192G J0HA7195G L0HA7794G L0HA7818G L0HA7815G L0HA7804G H9HB0934GR L9HB2176GR D0HB4296G C0HB4122GR D9HB9695G F9HB0324G F9HB0497G E0HB4448G E0HB4502G E0HB4547G E0HB4604G E0HB4616G E0HB4680G E0HB4687G E0HB4819G E0HB4881G F0HB5010G D0HC0713G J0HB5841G J0HB5865G J0HB5975G M0HB6696G M0HB6711G M0HB6760G M0HB6922G M0HB6925G M0HB6950G M0HB6953G M0HB6971G M0HB6973G M0HB6974G M0HB6976G M0HB6977G M0HB6979G M0HB6980G M0HB6982G M0HB6983G M0HB6986G M0HB6989G M0HB6990G M0HB6994G M0HB6995G M0HB6996G M0HB6999G M0HB7000G M0HB7001G M0HB7002G M0HB7006G M0HB6968G M0HB6988G M0HB6991G M0HB7010G M0HB7011G M0HB7012G M0HB7013G M0HB7015G M0HB7016G M0HB7017G M0HB7018G M0HB7019G M0HB7020G M0HB7023G M0HB7024G M0HB7025G M0HB7026G M0HB7028G M0HB7029G A1HB7547G A1HB7598G A1HB7601G A1HB7604G M0HB6970G C1HB8191G C1HB8220G C1HB8224G H1HB9502G H1HB9503G H1HB9504G H1HB9513G J9HB1067GR J9HB1245GR M9HB2825GR M9HB2899GR A0HB3179GR A0HB3216GR C0HA6610G C0HA6649G C0HA6503G C0HA6510G J0HB5995G K0HB6241G K0HB6275G K0HB6301G B1HB7863G C1HB8082G C1HB8088G C1HB8092G C1HB8107G C1HB8108G C1HB8136G C1HB8137G C1HB8147G C1HB8156G C1HB8162G C1HB8163G C1HB8170G C1HB8175G C1HB8176G C1HB8178G C1HB8210G C1HB8219G C1HB8230G D1HB8610G D1HB8632G H1HD4215F RT405160722GA RT407206340GA RT407206403GA RT407226441GA SCS07171073GA SCS07171078GA SCS07140998GA RT407266610GA SCS07461977GA RT407487540GA RT407517574GA RT407517605GA RT407517619GA RT408027651GA RT408298081GA RT408298094GA RT408338100GA RT408338106GA RT408338108GA RT408338115GA RT408338118GA RT408338122GA RT408338129GA RT408338131GA RT408338141GA RT408358146GA RT408358150GA RT408358151GA RT408358153GA RT408358154GA RT408418385GA RT408418423GA RT408438511GA RT408438512GA RT408438542GA RT408478600GA RT408478648GA RT408468610GA RT408478606GA SC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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		 Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
FDA Determined
Cause 2		 Pending
Action GE Healthcare sent an Urgent Medical Device Correction letter dated December 5, 2013, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044. For questions regarding this recall call 262-513-4122.
Quantity in Commerce 1,948 (1,834 US; 114 OUS)
Distribution Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATES, VENEZUELA, CHILE, CANADA, and BERMUDA.
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
510(K)s with Product Code = MHX and Original Applicant = GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
510(K)s with Product Code = MHX and Original Applicant = MARQUETTE ELECTRONICS, INC.
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