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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81957

9 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 09, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America, LLC

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

9 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 9

PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Z-0853-2019
Recall number
Z-0853-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
15,064

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

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Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 2 of 9

PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Z-0854-2019
Recall number
Z-0854-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
11332

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

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Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 3 of 9

PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Z-0855-2019
Recall number
Z-0855-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
13239

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

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Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 4 of 9

PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Z-0856-2019
Recall number
Z-0856-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
14067

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

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CN31608866 CN31608867 CN31608868 CN31608869 CN31608870 CN31608871 CN31608872 CN31608873 CN31608874 CN31608875 CN31608876 CN31608877 CN31608878 CN31608879 CN31608880 CN31608881 CN31608882 CN31608883 CN31608884 CN31608885 CN31608886 CN31608887 CN31608888 CN31608889 CN31608890 CN31608891 CN31608892 CN31608893 CN31608894 CN31608895 CN31608896 CN31608897 CN31608898 CN31608899 CN31608900 CN31608901 CN31608902 CN31608903 CN31608904 CN31608905 CN31608906 CN31608907 CN31608908 CN31608909 CN31608910 CN31608911 CN31608912 CN31608913 CN31608914 CN31608915 CN31608916 CN31608917 CN31608918 CN31608919 CN31608920 CN31608921 CN31608922 CN31608923 CN31608924 CN31608925 CN31608926 CN31608927 CN31608928 CN31608929 CN31608930 CN31608931 CN31608932 CN31608933 CN31608934 CN31608935 CN31608936 CN31608937 CN31608938 CN31608939 CN31608940 CN31608941 CN31608942 CN316089

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 5 of 9

PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients

Z-0857-2019
Recall number
Z-0857-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
57

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

US21512485 US21512486 US21512487 US21512488 US21512489 US21512490 US31722466 US31722467 US31722468 US31722469 US41513026 US61722772 US61722773 US71621391 US71722865 US71722866 US81208557 US81208558 US81309947 US81411777 US81411819 US81411820 US81621422 US91412024 US91412025 US91412026 US91513515 US91513521 US91513522 US91513585 US91621626 USD1513746 USN1621889 USN1723144 USN1723145 USO1310393 USO1310394 USO1310395 USO1310396 USO1513640 USO1621655 USO1831199 USO1831200 USO1831201 USO1831202 USO1831208 USO1831209 USO1831210 USO1831211 USO1831212 USO1831213 USO1831214 USO1831215 USO1831216 USO1831217 USO1831218 USO1831219

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 6 of 9

PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Z-0858-2019
Recall number
Z-0858-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

US91412044 USO1513631

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 7 of 9

PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Z-0859-2019
Recall number
Z-0859-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

US41510645 US41510646 US71630792 USN1206382 USN1206383 USN1409879 USO1631023

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 8 of 9

PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Z-0860-2019
Recall number
Z-0860-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

USN1800002 USN1800003 USN1800004

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 9 of 9

PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Z-0861-2019
Recall number
Z-0861-2019
Initiated
January 09, 2019
Classification
Class II
Status
Ongoing
Quantity
14

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Code information

US31510433 US31630351 US31630352 US31630353 US51510712 US51510713 US61510947 US61630668 US61630669 US81731977 US81731978 US91511381 US91511445 USO1511461

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.