[pending] IntelePACS - InteleConnect / TechPortal
Pending LLM rewrite. Source: FDA_DEVICE Z-0723-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- IntelePACS - InteleConnect / TechPortal
- Manufacturer
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- PACS-5-7-1-R42 through R47/26 June 2025 - 25 Sep 2025
- PACS 5-8-1-R20 through R23/26 Jun 2025 - 25 Sep 2025
- PACS-5-9-1-R1 through R3/30 Jun 2025 - 09 Sep 2025
Distribution
Distributed nationwide across the United States.
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