{"url_path":"/fda/device/recalls/Z-2767-2026","section_key":"summary","section_title":"DEVICE Recall: PIE Medical Imaging B.V. — 3mensio Workstation (Vascular Fenestrated) software","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-07","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2767-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"PIE Medical Imaging B.V."},"word_count":149,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2767-2026\n\n**Recalling firm:** PIE Medical Imaging B.V.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-07\n**Report date:** 2026-07-29\n\n## Product\n3mensio Workstation (Vascular Fenestrated) software\n\n## Reason\nUser 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\n\n## Affected lots\nSoftware Version 10.7. UDIs: (01)08056304455925(11)250423(8012)10.7, (01)08056304455925(11)250523(8012)10.7 SP1, (01)08056304455925(11)250714(8012)10.7 SP2, (01)08056304455925(11)250729(8012)10.7 SP3, (01)08056304455925(11)251016(8012)10.7 SP4, (01)08056304455925(11)251103(8012)10.7 SP5\n\n## Distribution\nWorldwide - 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."}