INTELERAD MEDICAL SYSTEMS INCORPORATED
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for INTELERAD MEDICAL SYSTEMS INCORPORATED and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-03FDA-DeviceClass IIIntelePACS - InteleConnect / TechPortal
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
- 2025-03-05FDA-DeviceClass IIIntelePACS (Image Fusion Module) - InteleViewer
A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.
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