--- title: "PIE Medical Imaging B.V. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search PIE Medical Imaging B.V. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/pie-medical-imaging-b-v/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # PIE Medical Imaging B.V. recall records **2** reported ongoing 2 records in this archive. Latest source date May 7, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 7, 2026 FDA device enforcement ### [3mensio Workstation (Vascular Fenestrated) software](https://isitonrecall.com/recall/fda-device-z-2767-2026-3mensio-workstation-vascular-fenestrated-software/) 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... Class II Reported ongoing 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, Nether... [Official source for 3mensio Workstation (Vascular Fenestrated) software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2767-2026%22) Jul 14, 2025 FDA device enforcement ### [3mensio Workstation (Vascular Fenestrated) software](https://isitonrecall.com/recall/fda-device-z-2297-2025-3mensio-workstation-vascular-fenestrated-software/) When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC. [Official source for 3mensio Workstation (Vascular Fenestrated) software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2297-2025%22) ## Reasons in these listed records - 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 ... - When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position... These examples come from this result page and are not a ranking of every recall reason. ## Checking PIE Medical Imaging B.V. ### Is there a recall on pie medical imaging b.v. right now? This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search PIE Medical Imaging B.V.](https://isitonrecall.com/check/?q=PIE%20Medical%20Imaging%20B.V.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)