INTELERAD MEDICAL SYSTEMS INCORPORATED: IntelePACS - InteleConnect / TechPortal
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Product
- IntelePACS - InteleConnect / TechPortal
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
- Recall initiated
- 2025-10-17
- Code info
- UDI-DI: B228INTELEPACS0. Version/Dates of Distribution: PACS-5-6-1-R64 through R68/02 Jul 2025 - 10 Sep 2025, 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
- Product quantity
- 19
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Montreal
- State
- N/A
- Country
- Canada
- Event id
- 97868
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