Intellispace Portal software — Class II medical device recall Z-1988-2012
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-07-18, distributed nationwide. Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformance
| Recall number | Z-1988-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2012-05-23 |
| Classified | 2012-07-11 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-03-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CN, CZ, DK, FR |
| Quantity | 96 |
| Reason classes | software |
| Serial numbers | 30003, 30007, 30018, 30019, 30036, 35006, 79916, 79933, 79937, 79940, 80425, 80818, 80891, 80910, 80914, 80965, 80966, 80980, 81013, 81026, 81028, 81097, 81098, 81127, 81132 and 43 more |
| Model numbers | 881001 |
Product
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.