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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65843

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 27, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Radiometer America Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1930-2013
Recall number
Z-1930-2013
Initiated
November 27, 2012
Classification
Class II
Status
Terminated
Recalling firm
Radiometer America Inc
Quantity
5,874 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.

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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391-880R0107N005, 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.

Distribution pattern

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.