Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69197

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

Open FDA event record

Event summary

Timeline bucket
August 08, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems, 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

Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

Z-0022-2015
Recall number
Z-0022-2015
Initiated
August 08, 2014
Classification
Class II
Status
Terminated
Quantity
one system

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

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

Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

Code information

Model Number: Integris Allura 15-12 Serial Number: 16741023

Distribution pattern

US distribution to FL