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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74083

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 10, 2015
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

2 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 2

Philips Healthcare DigitalDiagnost stationary X-ray system

Z-1695-2016
Recall number
Z-1695-2016
Initiated
November 10, 2015
Classification
Class II
Status
Terminated
Recalling firm
Philips Healthcare
Quantity
160

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

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

The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

Code information

software version - 4.0.4, 4.1.2, 4.1.3.

Distribution pattern

USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.

device · product 2 of 2

Philips Healthcare DuraDiagnost stationary X-ray system

Z-1696-2016
Recall number
Z-1696-2016
Initiated
November 10, 2015
Classification
Class II
Status
Terminated
Recalling firm
Philips Healthcare
Quantity
5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

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

The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

Code information

software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5

Distribution pattern

USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.