Reported Aug 20, 2014 · Terminated
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace…
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 Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
- Lot codes and dates
- ISP DX/HX/EX;ISP IX;
646 of 646 codes
881001870081852548700448700659501048504595027822028531987187851708524485218950309200385166851728716285330853378516495038950129870037871938211780905850429200058086495057950094851048535995008485180950071850001872018701485588856078562385619809748557880752856288562785637856018089885599855948562985585856368566885584
ISP LX SPECT;444 of 444 codes
881030162771627940066400064007740233400201400235402042000120003402644029640294401111049215142159294003740031400361576416515200091539816371400714002460001240110600027400924007040168401624024440057401364007640101400228700327006770044700717002270038854217007570081700077005370011700197004070018700547001570002
881035400844009340087401334014140033401344002264000340022740001
- ISP DX/HX/EX;
- Amount recalled
- 1099 Units
Where it was sold
Why it was recalled
The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (
This product could cause temporary or reversible health problems — stop using it.
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