Reported Jul 18, 2012 · Terminated
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Road · Cleveland, OH · 44143-2131
Is this the product you have?
- Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
- Lot codes and dates
- Model number 881001
- Serial numbers
67 of 67 codes
811727993785083810978514579916811328501182020850078500685081810288091482004850418118082016300198091081133810988116979940809808203682007850848508582039811278116530003808183000785042811848202182030820238205182026820248202882050820258202982027300187993382015850893003681183820378042581157850258201181174
- Amount recalled
- 96
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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