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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85603

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

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Event summary

Timeline bucket
April 23, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

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

ProxiDiagnost N90, UDI 706100

Z-2256-2020
Recall number
Z-2256-2020
Initiated
April 23, 2020
Classification
Class II
Status
Terminated
Quantity
91

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.

Code information

Serial Numbers: SN18000022 SN19000005 10000047 SN18000019 20000047 20000054 10000011 10000021 10000010 10000026 10000015 SN18000011 10000000 10000009 10000004 10000005 SN18000015 SN19000008 SN19000009 10000019 10000036 20000052 SN18000007 10000033 SN18000014 10000001 10000039 20000051 SN18000004 SN18000016 SN18000018 SN19000004 SN19000011 SN19000015 SN19000018 10000008 20000045 20000053 10000006 10000022 10000048 10000017 10000012 20000039 20000044 SN19000014 10000040 10000043 SN19000017 20000026 SN19000012 SN18000006 SN18000012 SN18000017 10000014 SN18000013 SN19000013 10000030 SN18000225 SN18000024 10000049 SN19000007 SN19000010 10000041 10000046 SN18000009 SN19000001 SN19000016 10000023 10000024 10000025 10000050 20000043 10000028 SN18000002 10000020 SN18000003 SN18000023 SN19000002 SN19000003 SN19000006 10000013 10000016 10000018 SN18000020 SN18000005 20000048

Distribution pattern

Domestic distribution nationwide. Foreign distribution to Chile and Germany.