FDA-Device2025-12-03Class IIPROCESSING DEFECT
IntelePACS - InteleConnect / TechPortal
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
Affected count
19
Manufactured in
800, Boul. de Maisonneuve Est, 12th floor, Montreal, N/A, Canada
Products
IntelePACS - InteleConnect / TechPortal
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2026Want us to check the next one for you?
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