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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83654

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

Open FDA event record

Event summary

Timeline bucket
December 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Healthcare

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

DigitalDiagnost C50, Stationary X-ray System

Z-2498-2019
Recall number
Z-2498-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Philips Healthcare
Quantity
2

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
missing label

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

During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.

Code information

Product Number 712201 System Serial Number: SN170053 SN180074

Distribution pattern

Puerto Rico