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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97682

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

Open FDA event record

Event summary

Timeline bucket
September 29, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

Z-0241-2026
Recall number
Z-0241-2026
Initiated
September 29, 2025
Classification
Class II
Status
Ongoing
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

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

Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

Code information

Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;

Distribution pattern

Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.