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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68979

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

Open FDA event record

Event summary

Timeline bucket
July 24, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Healthcare Informatics, Inc.

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 IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

Z-2252-2014
Recall number
Z-2252-2014
Initiated
July 24, 2014
Classification
Class II
Status
Terminated
Quantity
109 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
problem was detected in the Philips IntelliSpace PAC 4.4 software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.

Code information

IntelliSpace 4.4

Distribution pattern

US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.