Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IntelliSpace Portal (ISP) DX/HX/EX Recalled by Philips Medical Systems (Cleveland) Inc Due to The following software issues have been identified in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.
Affected Products
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.
Quantity: 1099 Units
Why Was This Recalled?
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 (
Where Was This Sold?
This product was distributed to 36 states: AL, AK, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, WA, WV, WI, WY
About Philips Medical Systems (Cleveland) Inc
Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report