Z-1678-2014Class II

IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT...

Name: Z-1678-2014 IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-03-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-03-11 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2014-03-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1678-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Posted: 2014-06-02
Terminated: 2015-08-04
Recalling firm: Philips North America LLC
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.
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1678-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1678-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code KPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)