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Recall Observatory FDA recall evidence

Device product

IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.

Z-1678-2014

March 11, 2014

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 68179
Status
Terminated
Classification
Class II
Quantity
157 units
Official record key
device-enforcement:Z-1678-2014

Official wording

Reason: During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.

Code information: ISP DX/HX/EX; Model number 881001, Serial numbers 35033, 85298, 80861, 81017, 81021, 81191, 82085, 82124, 82144, 82148, 82242, 85029, 85030, 85033, 85164, 85166, 85183, 85247, 85302, 85324, 85337, 85353, 85357, 85359, 85397, 85401, 85402, 87004, 87014, 87158, 87176, 87177, 87182, 87200, 92003, 95043, 95044, 95045, 95046, 95047, 95048, 95049, 95050, 95051, 95052, 95054, 850001, 870030, 870071, 870073, 870076, 920007, 920008, 950006, 950023, 950031, 950039, 950041, 950045, 950052, 950071, 950084, 950085, 950087, 950106, 950119, 950120, 950121, 950129, 950137, 950143 and 950146. ISP IX; Model number 881030, Serial numbers 40024, 40021, 40031, 40036, 40044, 40061, 40082, 40088, 40096, 40145, 40146, 40148, 40150, 40155, 40158, 40160, 40169 and 600003. ISP LX SPECT; Model number 881035, Serial numbers 40001, 40003, 40033, 40084, 40087, 40093, 40133, 40134 and 40141.

Distribution pattern: Worldwide distribution, including US nationwide, Argentina, Australia, Austria, Canada, Cayman Islands, Chile, Denmark, Finland, France, Germany, India, Iraq, Israel, Italy, Latvia, Malaysia, Mexico, Netherlands, Panama, Peru, Poland, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Turkey and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.