Class 2 Device Recall TCM4 series Base Unit

• Date Initiated by Firm: November 27, 2012
• Date Posted: August 08, 2013
• Recall Status: Terminated on June 16, 2014
• Recall Number: Z-1930-2013
• Recall Event ID: 65843
• 510(K)Number: K043003 K001866
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code LPP
• Product: TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, 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, 391-876R0017N002, 391-876R0018N004-391-876R0018N009, 391-876R0019N001, 391-876R0019N008-391-876R0019N010, 391-876R0020N001, 391-876R0022N002-391-876R0022N008, 391-876R0022N009-U, 391-876R0023N001, 391-876R0023N006, 391-876R0023N009, 391-876R0024N001-391-876R0024N003, 391-876R0024N005, 391-876R0024N006, 391-876R0026N001, 391-876R0026N002, 391-876R0026N005, 391-876R0026N006, 391-876R0027N007, 391-876R0027N008, 391-876R0028N002, 391-876R0028N018-391-876R0028N020, 391-876R0029N005, 391-876R0029N007, 391-876R0029N009, 391-876R0029N012, 391-876R0029N019, 391-876R0030N001, 391-876R0030N002, 391-876R0030N006-391-876R0030N008, 391-876R0031N009, 391-876R0031N011, 391-876R0031N012, 391-876R0031N013, 391-876R0031N016, 391-876R0031N020, 391-876R0032N020, 391-876R0032N018, 391-876R0033N003, 391-876R0033N005, 391-876R0034N004, 391-876R0034N004U, 391-876R0034N006, 391-876R0034N007, 391-876R0034N009, 391-876R0034N010, 391-876R0034N017, 391-876R0034N018, 391-876R0035N005, 391-876R0035N006, 391-876R0035N007U, 391-876R0035N008, 391-876R0035N017, 391-876R0036N001, 391-876R0036N003, 391-876R0036N004, 391-876R0036N007, 391-876R0036N008, 391-876R0036N010, 391-876R0036N011, 391-876R0036N013, 391-876R0036N016, 391-876R0037N010, 391-876R0037N012, 391-876R0037N013, 391-876R0038N003, 391-876R0038N017, 391-876R0039N003, 391-876R0039N004, 391-876R0039N006, 391-876R0039N008, 391-876R0039N009, 391-876R0039N011, 391-876R0039N012, 391-876R0040N001, 391-876R0040N001U, 391-876R0040N015, 391-876R0040N018, 391-876R0040N019, 391-876R0041N003, 391-876R0041N004, 391-876R0041N005, 391-876R0041N011U, 391-876R0041N012-391-876R0041N016, 391-876R0042N001, 391-876R0042N005-391-876R0042N012, 391-876R0042N015, 391-876R0042N020, 391-876R0043N001, 391-876R0043N002, 391-876R0043N004-391-876R0043N009, 391-876R0043N014, 391-878R0002N001, 391-878R0002N002, 391-878R0002N004-391-878R0002N006, 391-878R0004N008, 391-878R0004N009, 391-878R0004N013-391-878R0004N015, 391-878R0004N018-391-878R0004N020, 391-878R0005N001, 391-878R0005N002, 391-878R0005N011-391-878R0005N013, 391-878R0005N015, 391-878R0005N020, 391-878R0006N003, 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391-878R0018N004-391-878R0018N013, 391-878R0018N016, 391-878R0018N017, 391-878R0019N001-391-878R0019N004, 391-878R0019N006, 391-878R0019N020, 391-878R0020N001-391-878R0020N006, 391-878R0020N012-391-878R0020N016, 391-878R0020N018, 391-878R0020N019, 391-878R0021N009 391-878R0021N010, 391-878R0021N011, 391-878R0022N017, 391-878R0023N013, 391-878R0023N014, 391-878R0023N019, 391-878R0023N020, 391-878R0024N002, 391-878R0024N003, 391-878R0024N006, 391-878R0024N008, 391-878R0024N010, 391-878R0024N011, 391-878R0024N015, 391-878R0025N002, 391-878R0025N004-391-878R0025N014, 391-878R0026N003, 391-878R0026N004, 391-878R0026N006, 391-878R0027N008, 391-878R0027N015, 391-878R0027N017, 391-878R0027N018, 391-878R0027N020, 391-878R0028N002, 391-878R0028N003, 391-878R0028N005, 391-878R0028N007-391-878R0028N009, 391-878R0028N015-391-878R0028N017, 391-878R0028N020, 391-878R0029N002-391-878R0029N004, 391-878R0029N018, 391-878R0029N019, 391-878R0030N001, 391-878R0030N010, 391-878R0030N011, 391-878R0030N020, 391-878R0031N009-391-878R0031N011, 391-878R0031N013, 391-878R0031N015, 391-878R0031N016, 391-878R0032N001, 391-878R0032N003, 391-878R0032N010, 391-878R0032N014, 391-878R0032N015, 391-878R0032N016, 391-878R0032N020, 391-878R0033N001, 391-878R0033N008-391-878R0033N012, 391-878R0034N0013, 391-878R0034N006, 391-878R0034N007U, 391-878R0034N014-391-878R0034N020, 391-878R0035N001, 391-878R0035N006-391-878R0035N011, 391-878R0035N014, 391-878R0036N001-391-878R0036N004, 391-878R0036N010, 391-878R0036N012-391-878R0036N016, 391-878R0037N004-391-878R0037N008, 391-878R0037N010-391-878R0037N012, 391-878R0038N010-391-878R0038N013, 391-878R0038N019, 391-878R0038N020, 391-878R0039N001, 391-878R0039N009-391-878R0039N020, 391-878R0040N002-391-878R0040N005, 391-878R0040N014-391-878R0040N017, 391-878R0041N011-391-878R0041N014, 391-878R0042N007-391-878R0042N011, 391-878R0043N001, 391-878R0043N004, 391-878R0043N010, 391-878R0043N011, 391-878R0043N015-391-878R0043N018, 391-878R0044N011D, 391-878R0044N012-391-878R0044N019, 391-878R0045N001-391-878R0045N003, 391-878R0045N006, 391-878R0045N008, 391-878R0045N018-391-878R0045N020, 391-878R0046N001-391-878R0046N003, 391-878R0047N010, 391-878R0047N012-391-878R0047N015, 391-878R0047N018-391-878R0047N020, 391-878R0048N001-391-878R0048N012, 391-878R0049N002-391-878R0049N016, 391-878R0050N001-391-878R0050N005, 391-878R0050N007, 391-878R0050N008, 391-878R0050N012-391-878R0050N019, 391-878R0052N007, 391-878R0052N011-391-878R0052N020, 391-878R0053N003, 391-878R0053N007, 391-878R0053N009, 391-878R0053N011-391-878R0053N014, 391-878R0055N001, 391-878R0055N002, 391-878R0055N004, 391-878R0056N013-391-878R0056N015, 391-878R0057N011-391-878R0057N017, 391-878R0058N002, 391-878R0058N006, 391-878R0058N007, 391-878R0058N011, 391-878R0058N013, 391-878R0059N011, 391-878R0059N012, 391-878R0059N014-391-878R0059N019, 391-878R0060N001, 391-878R0060N007, 391-878R0060N008, 391-878R0061N002-391-878R0061N016, 391-878R0061N022-391-878R0061N028, 391-878R0062N022-391-878R0062N024, 391-878R0062N029-391-878R0062N032, 391-878R007N014, 391-880 R0117N017, 391-8801R0059N007, 391-880L0027N012 391-880R0005N005, 391-880R0006N001-391-880R0006N009, 391-880R0006N012 391-880R0006N013, 391-880R0006N020, 391-880R0007N003-391-880R0007N011, 391-880R0007N018, 391-880R0008N001, 391-880R0008N007-391-880R0008N010, 391-880R0009N001-391-880R0009N003, 391-880R0009N002, 391-880R0009N003, 391-880R0009N012, 391-880R0009N014-391-880R0009N016, 391-880R0009N020, 391-880R0010N002-391-880R0010N009, 391-880R0010N014, 391-880R0010N015, 391-880R0010N017, 391-880R0010N020, 391-880R0011N003, 391-880R0011N004, 391-880R0011N020, 391-880R0012N001-391-880R0012N009, 391-880R0012N012, 391-880R0013N005-391-880R0013N010, 391-880R0013N012, 391-880R0013N013, 391-880R0013N015, 391-880R0013N016, 391-880R0015N004-391-880R0015N010, 391-880R0015N020, 391-880R0016N001, 391-880R0017N002-391-880R0017N004, 391-880R0017N006-391-880R0017N010, 391-880R0017N013, 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R0030N007, R0041N001, R0048N005, R035N001 & TCMXX 00000154R00.
• Recalling Firm/ Manufacturer: Radiometer America Inc; 810 Sharon Dr; Westlake OH 44145-1521
• For Additional Information Contact: Mr. 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: Device Design
• Action: On 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 Commerce: 5,874 units
• Distribution: Worldwide 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 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 = LPP and Original Applicant = RADIOMETER MEDICAL A/S; 510(K)s with Product Code = LPP and Original Applicant = RADIOMETER MEDICAL APS