Recall Z-1988-2012— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-05-23, terminated 2013-03-28. It names 3 FDA 510(k) clearances: K060937, K033326, K012009. 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: 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.
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-23
- Terminated
- 2013-03-28
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K060937 — BRILLIANCE VOLUME
- K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
- K012009 — MX8000 IDT CT SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.