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Terminated

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.

FDA Recall Z-1678-2014 · Posted 2014-06-02

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2014-03-11
Date Terminated2015-08-04
Product Quantity157 units

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.

Firm Action

On 03/10/2014 the firm sent Urgent Medical Device Correction Letters to their customers.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110151ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TPhilips Health Care · 2011-03-22K060937BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc. · 2006-06-05K033326PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems, Inc. · 2003-10-29K012009MX8000 IDT CT SYSTEMMarconi Medical Systems, Inc. · 2001-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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