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.
FDA Recall Z-1506-2016 · Posted None
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-03-04
Date Terminated2018-07-02
Product Quantity33 Units
Reason for Recall
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.
Firm Action
On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips representative.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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