FDA Device recall Z-1208-2025
IntelePACS (Image Fusion Module) - InteleViewer
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of IntelePACS (Image Fusion Module) - InteleViewer by Intelerad Medical Systems, citing 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) incor….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1208-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-05 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Intelerad Medical Systems |
| Distribution | US |
Product
IntelePACS (Image Fusion Module) - InteleViewer
Reason
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.
Identifiers
| code_info | UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1208-2025%22
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