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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86416

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

Open FDA event record

Event summary

Timeline bucket
November 20, 2019
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

Z-3023-2020
Recall number
Z-3023-2020
Initiated
November 20, 2019
Classification
Class II
Status
Terminated
Quantity
71

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

Code information

All ProxiDiagnost N90 systems are affected.

Distribution pattern

United States