{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "191504", "product_res_number": "Z-0639-2022", "event_date_initiated": "2021-12-23", "event_date_created": "2022-02-16", "recall_status": "Open, Classified", "res_event_number": "89414", "product_code": "FSA", "product_description": "Liko Mobile Lifts: Primarily intended for use in nursing homes\nLiko M220, Model 2050010", "code_info": "Serial numbers: 5263715-5269464. Manufactured between 2016-DEC-27 and 2021-SEP-01.\n\nUDI: 0887761GMN000034U5", "firm_fei_number": "1824206", "recalling_firm": "Hill-Rom, Inc.", "address_1": "1069 State Road 46 E", "city": "Batesville", "state": "IN", "postal_code": "47006-7520", "additional_info_contact": "Howard Karesh \n312-237-6188", "reason_for_recall": "Missing bushing on Liko M220 and M230 causing wear and potential for patient falling", "root_cause_description": "Process control", "action": "HillRom issued Urgent Medical Device Correction Letter (FSCA Identifier: FA 2021-010-002-LUL-001) via third party on 23 December 2021 via UPS Ground Service to Distributors and Direct Users. Letter states reason for recall, health risk and action to take:\n1. Review the product label on your Liko M220/M230 to determine if it is impacted by this field action by identifying the manufacturing date of the device (i.e. Manufacturing date\nbetween 2016-DEC-27 and 2021 SEP-01). See figure 2.\n\n2. Please periodically inspect your Liko device for damage or wear. Report visible wearing or damage to your Technical Support Team do not use the device until Technical Support can inspect and repair where necessary.\n3. Please fill out the attached response form and return it to Hillrom\nhillromLUL001@sedgwick.com within two weeks Please share this Field Safety Notice with your end users and complete the attached response form and return to hillromLUL001@sedgwick.com within two weeks. Contact hillromLUL001@sedgwick.com to receive an electronic copy of this notification and response\nform for onward distribution. Action to be taken by the Hillrom:\nUpon receipt of the response form, identifying potentially impacted devices, Hillrom or an official Hillrom distributor/representative will be in contact to schedule inspection of your device to confirm presence of the bushing. Where it is confirmed the device is missing the bushing, a replacement slingbar with the bushing will be installed.\n\nIf you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or technical.support@hillrom.com", "product_quantity": "5470 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Austria, Austria, Bahrain, \nCanada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, \nGreece, Hong Kong, Ireland, Israel, Italy, Norway, Saudi Arabia, Sweden, Slovenia, \nTaiwan (Province of China), South Africa, Oman.", "openfda": { "k_number": [ "K841395", "K841398", "K930625", "K844976", "K860837", "K840997", "K942807", "K780684", "K902141", "K823206", "K792601", "K811899", "K851844" ], "registration_number": [ "3009709183", "3013875443", "2183887", "9615246", "3007309299", "3033790380", "3005260401", "3009402404", "3016678044", "3010113803", "3013524663", "2132280", "3004905643", 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