{"recall":{"id":"fda-device-99596","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"IMRIS Imaging Inc recalls 2 products","firm":"IMRIS Imaging Inc","date":"2026-08-06","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000","code":"113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997","quantity":"6 units","number":"Z-3033-2026","classification":"Class II"},{"name":"ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600","code":"114093-000 - 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","quantity":"13 units","number":"Z-3034-2026","classification":"Class II"}],"reason":"The 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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.","nationwide":true,"states":[],"units":"6 units; 13 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99596","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"78bc64d3b3152a8b","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99596","record":[{"status":"Ongoing","city":"Chaska","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99596","recalling_firm":"IMRIS Imaging Inc","address_1":"1230 Chaska Creek Way Ste 100","address_2":"N/A","postal_code":"55318-2707","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.","recall_number":"Z-3033-2026","product_description":"ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000","product_quantity":"6 units","reason_for_recall":"The 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.","recall_initiation_date":"20260806","center_classification_date":"20260826","report_date":"20260902","code_info":"113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997"},{"status":"Ongoing","city":"Chaska","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99596","recalling_firm":"IMRIS Imaging Inc","address_1":"1230 Chaska Creek Way Ste 100","address_2":"N/A","postal_code":"55318-2707","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.","recall_number":"Z-3034-2026","product_description":"ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600","product_quantity":"13 units","reason_for_recall":"The 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.","recall_initiation_date":"20260806","center_classification_date":"20260826","report_date":"20260902","code_info":"114093-000 - 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"}]}}