IntelePACS - InteleConnect / TechPortal
FDA device recall Z-0723-2026 · posted 2025-11-26 · Open, Classified
Recall details
- Recalling firm
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Reason for recall
- 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.
- Action taken
- On 10/17/2025, correction notices were emailed to customers who were asked to do the following: 1. Schedule Feature Release Upgrade (FRU) update immediately with the firm's Customer Success Manager (CSM). 2. Interim Mitigation: Until the update is applied, please advise all staff to verify the 'Relevant Clinical Info' field after any Case Editor modifications and consider temporarily documenting critical clinical information in alternative fields as backup. 3. complete and return the Acknowledgement Form via email to regulatory-affairs@intelerad.com. For more information or to ask any questions about the notification contact the firm's regulatory affairs department at regulatory-affairs@intelerad.com
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 19
- Distribution
- US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
- Date initiated
- 2025-10-17
- Date posted
- 2025-11-26
- Location
- Montreal, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IntelePACS (K192176) | Intelerad Medical Systems Incorporated | 2020-04-02 |