Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1678-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-03-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1678-2014
Date of alert
2014-03-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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