{"url_path":"/fda/device/recalls/Z-3034-2026","section_key":"summary","section_title":"DEVICE Recall: IMRIS Imaging Inc — ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-08-06","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3034-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"IMRIS Imaging Inc"},"word_count":128,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3034-2026\n\n**Recalling firm:** IMRIS Imaging Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-06\n**Report date:** 2026-09-02\n\n## Product\nORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600\n\n## Reason\nThe linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.\n\n## Affected lots\n114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119;  114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden."}