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PIE Medical Imaging B.V. FDA Recalls
2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| 3mensio Workstation (Vascular Fenestrated) softwareClass IIMay 7, 2026User measurement value reported by diagnostic bioimaging sof |
| 3mensio Workstation (Vascular Fenestrated) softwareClass IIJul 14, 2025When fenestrated analysis with clock measurements is started |