PIE Medical Imaging recalls

PIE Medical Imaging has 2 recalls on record with the FDA and USDA, the earliest in 2025 and the latest reported on 29 Jul 2026. 2 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls2since 2025

Last 12 months1reported

Class I00% of total

Ongoing2latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 1Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why pie medical imaging is recalled

Device Malfunction2100%

Product types

Heart & Vascular Devices2100%

By year

2026150%
2025150%

Ongoing pie medical imaging recalls

2 active

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	3mensio Workstation (Vascular Fenestrated) recalled	PIE Medical Imaging	Device Malfunction	Nationwide
20 Aug 2025Device	CLASS II	3mensio Workstation (Vascular Fenestrated) recalled	PIE Medical Imaging	Device Malfunction	Nationwide

All pie medical imaging recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	3mensio Workstation (Vascular Fenestrated) recalled	PIE Medical Imaging	Device Malfunction	Nationwide
20 Aug 2025Device	CLASS II	3mensio Workstation (Vascular Fenestrated) recalled	PIE Medical Imaging	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.