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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62107

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

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Event summary

Timeline bucket
May 23, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) 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

Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.

Z-1988-2012
Recall number
Z-1988-2012
Initiated
May 23, 2012
Classification
Class II
Status
Terminated
Quantity
96

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that diff

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

Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that diff

Code information

Model number 881001; Serial numbers: 81172, 79937, 85083, 81097, 85145, 79916, 81132, 85011, 82020, 85007, 85006, 85081, 81028, 80914, 82004, 85041, 81180, 82016, 30019, 80910, 81133, 81098, 81169, 79940, 80980, 82036, 82007, 85084, 85085, 82039, 81127, 81165, 30003, 80818, 30007, 85042, 81184, 82021, 82030, 82023, 82051, 82026, 82024, 82028, 82050, 82025, 82029, 82027, 30018, 79933, 82015, 85089, 30036, 81183, 82037, 80425, 81157, 85025, 82011, 81174, 80965, 80966, 81026, 35006, 82009, 81013, 82003 & 80891.

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Republic, Denmark, and France.