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Terminated

IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

FDA Recall Z-2237-2014 · Posted 2014-08-14

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-07-27
Date Terminated2016-02-02
Product Quantity1099 Units

Reason for Recall

The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (

Firm Action

Philips Healthcare issued an Urgent Medical Device Correction letter dated July 28, 2014, via certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Philips Key Market representative would distribute the FSN internationally. Additionally, a Field Service Engineer would contact each site to schedule a time to install the software update. Customers with questions were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America and Canada customers were instructed to contact the Customer Care Solutions Center at 1-800-722-9377, option 1. For questions regarding this recall call 978-659-7703.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VT, WA, WI, WV, WY,Washington D.C. and Internationally to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Congo, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, and Yemen.

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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