IntelePACS — Class II medical device recall Z-0723-2026
Ongoing recall by INTELERAD MEDICAL SYSTEMS INCORPORATED, reported 2025-12-03, distributed nationwide. Software application that receives digital images and data to be communicated, processed, manipulated, enhance
| Recall number | Z-0723-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | INTELERAD MEDICAL SYSTEMS INCORPORATED, Montreal, N/A, Canada |
| Recall initiated | 2025-10-17 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 19 |
| Reason classes | software |
Product
IntelePACS - InteleConnect / TechPortal
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0723-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.