IntelePACS — Class II medical device recall Z-1208-2025
Ongoing recall by INTELERAD MEDICAL SYSTEMS INCORPORATED, reported 2025-03-05, distributed nationwide. A software application that receives digital images and data from various sources has a bug in specific softwa
| Recall number | Z-1208-2025 |
|---|---|
| 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 | 2025-02-05 |
| Classified | 2025-02-21 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ |
| Quantity | 88 |
| Reason classes | software |
Product
IntelePACS (Image Fusion Module) - InteleViewer
Reason for recall
A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.
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-1208-2025. 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.