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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68262

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

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Event summary

Timeline bucket
May 05, 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 XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.

Z-1646-2014
Recall number
Z-1646-2014
Initiated
May 05, 2014
Classification
Class II
Status
Terminated
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed

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

When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed

Code information

Model XIRIS 8.1 version XIRIS 8.1.50.0

Distribution pattern

Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.