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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74685

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

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Event summary

Timeline bucket
September 17, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America Corporation

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 DuraDiagnost stationary X-ray system

Z-2682-2016
Recall number
Z-2682-2016
Initiated
September 17, 2015
Classification
Class II
Status
Terminated
Quantity
15

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].

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

Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].

Code information

SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093

Distribution pattern

US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.