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U.S. Department of Health and Human Services

Class 2 Device Recall TCM4 series Base Unit

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 Class 2 Device Recall TCM4 series Base Unitsee related information
Date Initiated by FirmNovember 27, 2012
Date PostedAugust 08, 2013
Recall Status1 Terminated 3 on June 16, 2014
Recall NumberZ-1930-2013
Recall Event ID 65843
510(K)NumberK001866 K043003 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code LPP
ProductTCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
Code Information TCM4 series Base Units: 000-154, 391-876, 391-878 and 391-880 below R0175N009 & Power Supply (Spare part): 910-246. Serial #: 154R0002N002, 154R0004N003, 154R0004N008, 154R0005N004, 154R0005N005, 154R0005N005-U, 154R0005N006-154R0005N006, 154R0006N005, 154R0006N006, 154R0006N008-154R0006N010, 154R0007N001-154R0007N010, 154R0008N001, 154R0008N002, 154R0008N002U, 154R0008N003, 154R0008N005-154R0008N010, 154R0009N004, 154R0009N010, 154R0011N003, 154R0011N006-154R0011N009, 154R0012N001-154R0012N003, 154R0013N004, 154R0013N005, 154R0013N007-154R0013N010, 154R0014N009, 154R0016N001-154R0016N003, 154R0016N008, 154R0016N009, 154R0016N010, 154R0017N007, 154R0019N001-154R0019N005, 154R0019N007, 154R0019N009, 154R0019N010, 154R0020N002, 154R0021N003, 154R0021N004U, 154R0021N005, 154R0021N008, 154R0021N010, 154R0022N008-154R0022N010, 154R0023N006, 154R0023N007, 154R0023N009, 154R0023N010, 154R0024N004-154R0024N006, 154R0024N009, 154R0024N010, 154R0025N002, 154R0025N004-154R0025N006, 154R0026N008, 154R0027N001-154R0027N005, 154R0027N007, 154R0028N001-154R0028N004, 154R0028N006-154R0028N006, 154R0029N003-154R0029N007, 154R0029N009, 154R0030N001, 154R0030N004-, 54R0030N007, 154R0030N008U, 154R0031N001, 154R0031N003-154R0031N009, 154R0034N006, 154R0034N008, 154R0034N009, 154R0035N002, 154R0035N003, 154R0035N006, 154R0035N008, 154R0035N009, 154R0035N010, 154R0036N010, 154R0036N002-154R0036N009, 154R0038N002-154R0038N006, 154R0040N001, 154R0040N002, 154R0040N009, 154R0040N010, 154R0041N001, 154R0041N003, 154R0041N004, 154R0041N006-154R0041N008, 154R0042N001, 154R0042N002, 154R0042N004, 154R0042N005, 154R0046N002, 154R0046N004, 154R0046N006-154R0046N008, 154R0047N002, 154R0048N002-154R0048N004, 154R0048N007, 154R0050N001-154R0050N009, 154R0051N001, 154R0051N003-154R0051N003, 154R0052N001-154R0052N009, 154R0053N007-154R0053N010, 154R0054N001, 154R0054N002, 154R0054N004, 154R0055N002-154R0055N006, 154R0056N001, 154R0056N002, 154R0056N005, 154R0056N006, 154R0056N008-154R0056N010, 154R0057N001-154R0057N004, 154R0057N008, 154R0057N009, 154R0058N001-154R0058N003, 154R0059N002-154R0059N004, 154R0059N006-154R0059N008 154R005N001, 154R0060N007-154R0060N009, 154R006N003, 154R0071N014, 154R031N010, 154R039N005, 154R039N006, 28N012, 28N013, 32N002, 381-880R0008N005 391-876R0001N003, 391-876R0001N006, 391-876R0001N007, 391-876R0001N010, 391-876R0002N004, 391-876R0002N009, 391-876R0003N001, 391-876R0003N004-391-876R0003N006, 391-876R0003N008, 391-876R0003N009, 391-876R0004N002, 391-876R0004N002U, 391-876R0004N009, 391-876R0004N014, 391-876R0005N003, 391-876R0005N004, 391-876R0006N011, 391-876R0007N007, 391-876R0007N008, 391-876R0007N010, 391-876R0011N001, 391-876R0011N002, 391-876R0011N009, 391-876R0011N010, 391-876R0012N002, 391-876R0012N002U, 391-876R0012N007, 391-876R0012N008, 391-876R0012N010, 391-876R0014N002, 391-876R0014N003, 391-876R0014N005, 391-876R0014N006, 391-876R0016N007, 391-876R0016N010, 391-876R0016N010U, 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391-880R0106N003, 391-880R0106N012, 391-880R0106N013, 391-880R0106N016, 391-880R0106N017, 391-880R0107N004, 391-880R0107N005, 391-880R0107N008, 391-880R0109N007, 391-880R0112N004, 391-880R0112N006-391-880R0112N008, 391-880R0114N001, 391-880R0115N006-391-880R0115N009, 391-880R0115N011, 391-880R0115N019, 391-880R0115N020, 391-880R0116N001-391-880R0116N003, 391-880R0123N017, 391-880R0128N001-391-880R0128N004, 391-880R0162N007, 391-880R0165N006, 391-880R0165N007, 876R0004N003, 876R0004N004, 876R0004N009, 876R0005N002, 876R0005N005, 876R0008N002, 876R0014N006, 876R0016N003, 876R0016N006, 876R0017N001, 876R0018N010U, 876R0019N007, 876R0021N001, 876R0021N003, 876R0022N002, 876R0023N002, 876R0023N003, 876R0023N005, 876R0023N006, 876R0024N004, 876R0027N009, 876R0028N013U, 876R0029N001, 876R0029N0013, 876R0029N0016, 876R0029N003, 876R0029N004, 876R0029N006, 876R0029N008, 876R0029N009, 876R0029N014, 876R0029N018, 876R0029N020-5, 876R0030N003, 876R0030N009, 876R0030N010, 876R0031N001, 876R0031N004-876R0031N007, 876R0031N018, 876R0031N019, 876R0032N004-876R0032N007, 876R0033N004, 876R0033N006, 876R0033N017, 876R0033N018, 876R0034N003, 876R0034N005, 876R0034N006, 876R0034N019, 876R0035N015, 876R0035N016, 876R0036N017, 876R0036N018, 876R0038N003, 876R0039N007, 876R0040N003, 876R0041N002, 876R0042N016, 876R0042N017, 876R0042N018, 876R0042N019, 876R0043N006, 878R0009N005, 878R0010N002, 878R0010N004, 878R0010N018, 878R0015N002U, 878R0015N008U, 878R0017N012, 878R0017N013, 878R0018N016, 878R0022N016, 878R0023N012, 878R0026N005, 878R0028N011, 878R0028N019, 878R0031N012, 878R0036N005, 878R0040N0001, 878R0040N013, 878R0044N020, 878R0055N002U, 880R0009N013, 880R0010N017-880R0010N019, 880R00113N019, 880R0011N002, 880R0013N014, 880R0022N006, 880R0026N005, 880R0037N011, 880R0040N008, 880R0045N005U, 880R0066N009, 880R0083N015U, 880R0083N019, 880R0095N013, 880R0097N010, 880R0106N014, 880R0106N015, 880R0107N001-880R0107N003, 880R0107N006, 880R0107N007, 880R0109N003-880R0109N006, 880R0109N008, 880R0111N004-880R0111N006, 880R0111N009, 880R0111N012-880R0111N015, 880R0111N017-880R0111N020, 880R0112N001, 880R0112N005, 880R0112N010, 880R0112N011, 880R0113N018, 880R0113N020, 880R0114N010-880R0114N017, 880R0114N020, 880R0115N001-880R0115N003, 880R0115N010, 880R0117N016, 880R0117N017, 880R0118N003, 880R0118N005-880R0118N009, 880R0118N013, 880R0118N014, 880R0118N017-880R0118N020, 880R0119N001-880R0119N013, 880R0120N015, 880R0121N002, 880R0121N003, 880R0121N005-880R121N011, 880R0121N013-880R0121N020, 880R0122N001, 880R0123N011-880R0123N015, 880R0124N020, 880R0125N001-880R0125N004, 880R0126N019, 880R0126N020, 880R0127N001-880R0127N008, 880R0127N010-880R0127N020, 880R0131N017-880R0131N020, 880R0132N001-880R0132N006, 880R0132N020, 880R0133N001-880R0133N013, 880R0133N017-880R0133N020, 880R0135N018-880R0135N020, 880R0136N001-880R0136N007, 880R0136N010-880R0136N020, 880R0137N001-880R0197N007, 880R0140N019, 880R0140N020, 880R0141N001-880R0141N015, 880R0141N019, 880R0142N001-880R0142N010, 880R0145N009-880R0145N017, 880R0146N011-880R0146N018, 880R0151N001, 880R0151N005-880R0151N008, 880R0151N016-880R0151N020, 880R0153N008, 880R0153N009, 880R0153N015-880R0153N017, 880R0154N014-880R0154N020, 880R0155N001-880R0155N003, 880R0155N012-880R0155N019, 880R0156N002, 880R0156N003, 880R0156N006, 880R0156N008, 880R0156N009, 880R0156N010, 880R0156N013, 880R0156N015, 880R0156N017, 880R0156N019, 880R0157N007, 880R0157N009, 880R0158N006, 880R0158N007, 880R0158N010, 880R0158N011, 880R0158N012, 880R0158N013, 880R0158N017, 880R0159N001, 880R0159N002, 880R0159N003, 880R0159N009, 880R0159N010-880R0159N019, 880R0161N014-880R0161N020, 880R0162N001-880R0162N005, 880R0165N008, 880R0165N009, 880R0165N010, 880R0167N003-880R0167N010, 880R0167N015, 880R0167N019, 880R0170N008, 880R0170N009, 880R0170N011, 880R0171N019, 880R0171N020, 880R0172N001, 880R0172N002, 880R0172N005, 880R0177N009, 880R0177N010, 880R0177N012, 880R0177N013, 880R0177N014, 880R0178N013, 880R0178N014, 880R0178N015, 880R0178N017-880R0178N020, 880R9999N999, 888R0178N016, R0011N002, R0014N012, R0016N008, R0027B009, R0027N009, R0030N007, R0041N001, R0048N005, R035N001 & TCMXX 00000154R00.
Recalling Firm/
Manufacturer
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1521
For Additional Information ContactMr. Matthew R. Ackerman
440-871-8900 Ext. 53485
Manufacturer Reason
for Recall
RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
FDA Determined
Cause 2
Device Design
ActionOn 11/30/2012 the firm sent an "Urgent Field Safety Notice" to their customers. The notification explained the issue and provided recommended actions. Customers may contact 1-800-736-0600 option 4 with questions.
Quantity in Commerce5,874 units
DistributionWorldwide distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LPP
510(K)s with Product Code = LPP
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