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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81706

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

Open FDA event record

Event summary

Timeline bucket
November 07, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems Gmbh, DMC

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

Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

Z-0612-2019
Recall number
Z-0612-2019
Initiated
November 07, 2018
Classification
Class II
Status
Terminated
Quantity
146

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

Code information

All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2

Distribution pattern

Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.