PIE Medical Imaging B.V. recalls
Every recall we track for PIE Medical Imaging B.V. — 2 in all, from 2025–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
2 recalls since 2017.
All FDA recall records for PIE Medical Imaging B.V. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 1 | 0 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled PIE Medical Imaging B.V. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All PIE Medical Imaging B.V. recalls
2 shown- Lower riskMedical device
PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software
PIE Medical Imaging recalls specific versions of 3mensio Workstation software for vascular imaging due to potential overestimation of cardiovascular measurements by up to 34.4% in certain use cases.
PIE Medical ImagingMay 7, 2026 - Use cautionMedical device
PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software
PIE Medical Imaging recalls 3mensio Workstation software versions 10.6-10.7 with clock position errors that may cause incorrect stent graft placement and tissue damage. Affected units sold from April 2024 to May 2025.
PIE Medical ImagingJul 14, 2025
PIE Medical Imaging B.V. recall questions
How many recalls has PIE Medical Imaging B.V. had?
2 recalls from PIE Medical Imaging B.V. are on record with U.S. safety agencies, from 2025–2026.
What is the most recent PIE Medical Imaging B.V. recall?
PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software, dated May 7, 2026. Every PIE Medical Imaging B.V. recall is listed on this page, newest first.
What should I do if I have a recalled PIE Medical Imaging B.V. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new PIE Medical Imaging B.V. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.