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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliSpace Portal

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 Class 2 Device Recall IntelliSpace Portal see related information
Date Posted June 02, 2014
Recall Status1 Terminated on August 04, 2015
Recall Number Z-1678-2014
Recall Event ID 68179
510(K)Number K110151  K060937  K033326  K012009 
Product Classification medical imaging software system - Product Code KPS
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.
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.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs. Kumudini J. Carter
440-483-7600
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
Action On 03/10/2014 the firm sent Urgent Medical Device Correction Letters to their customers.
Quantity in Commerce 157 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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