Class II — PIE Medical Imaging B.V.
| Recalling firm | Pie Medical Imaging B.V. |
|---|---|
| Registered facility | PIE MEDICAL IMAGING B.V. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information |
| Product | 3mensio Workstation (Vascular Fenestrated) software |
| Quantity | 165 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and the countries of United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, Belgium. |
| Initiated | 2026-05-07 |
| Classified | 2026-07-21 |
| Recall number | Z-2767-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PIE Medical Imaging B.V. (Z-2767-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98930/
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