Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application Recalled by Philips Medical Systems (Cleveland) Inc Due to The AutoSPECT Pro application was only designed to...
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 DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Quantity: 33 Units
Why Was This Recalled?
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
Where Was This Sold?
This product was distributed to 16 states: CO, DE, FL, GA, IL, IN, KS, MO, NV, NY, NC, OH, OR, PA, TN, TX
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