{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "112493", "product_res_number": "Z-0270-2013", "event_date_initiated": "2011-02-02", "event_date_posted": "2012-11-08", "recall_status": "Terminated", "event_date_terminated": "2014-05-14", "res_event_number": "63083", "product_code": "FNL", "product_description": "AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512.\n\nUsage: Hospital Bed.", "code_info": "Model #TL500; Serial Number: 001, 002, 003, 004, 005, 006, 007, 010, 013, 014, 015, 016, 017, 018, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 039, 040, 041, 042, 043, 044, 045, 046, 047, 048, 049, 050, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, 065, 070, 075, 081, 09350014, 09350015, 09350016, 09350017, 09350018, 09350021, 09350023, 09350025, 09350026, 09350027, 09350028, 09350029, 09350030, 09350031, 09350032, 09350033, 09350035, 09350038, 09350040, 09350041, 09350042, 09350045, 09350048, 09350049, 09350054, 09350055, 09350056, 09350057, 09350058, 09350059, 09350060, 09350062, 09350063, 09350064, 09350065, 09350066, 09350067, 09350068, 09350069, 09350070, 09350072, 09350074, 09350082, 09350085, 09350087, 09350088, 09350089, 09350090, 09350091, 09350092, 09430001, 09430002, 09430003, 09430004, 09430005, 09430006, 09430007, 09430008, 09430010, 09430013, 09430014, 09430015, 09430017, 09430019, 09430020, 09430021, 09430022, 09430024, 09430026, 09430027, 09430028, 09430029, 09430030, 09430032, 09430033, 09430034, 09430036, 09430037, 09430038, 09430039, 09430040, 09430041, 09430042, 09430043, 09430044, 09430045, 09430046, 09430047, 09430049, 09430050, 09430051, 09430052, 09430053, 09430054, 09430056, 09430057, 09430058, 09430059, 09430060, 09430061, 09430062, 09430063, 09430065, 09430066, 09463067, 09430068, 09430069, 09430070, 09430071, 09430072, 09430074, 09430075, 09430076, 09430077, 09430078, 09430079, 09430080, 09430081, 09430083, 09430085, 09430086, 09430087, 09430088, 09430089, 09430091, 09430093, 09430094, 09430097, 09430099, 09430100, 09520001, 09520002, 09520003, 09520004, 09520005, 09520006, 09520007, 09520008, 09520009, 09520011, 09520012, 09520013, 09520015, 09520017, 09520018, 09520019, 09520020, 09520021, 09520022, 09520025, 09520026, 09520027, 09520028, 09520029, 09520030, 09520031, 09520032, 09520033, 09520034, 09520035, 09520036, 09520037, 09520038, 09520039, 09520040, 09520041, 09520042, 09520043, 09520044, 09520045, 09520046, 09520047, 09520048, 09520049, 09520050, 10040001, 10040003, 10040004, 10040005, 10040006, 10040007, 10040008, 10040009, 10040010, 10040011, 10040012, 10040013, 10040014, 10040015, 10040016, 10040017, 10040028, 10040029, 10040030, 10040032, 10040033, 10040034, 10040035, 10040036, 10040037, 10040038, 10040039, 10040040, 10040041, 10040042, 10040043, 10040044, 10040045, 10040046, 10040047, 10040048, 10040049, 10040050, 10040051, 10040052, 10040053, 10040054, 10040055, 10040056, 10040057, 10040058, 10040059, 10040062, 10040063, 10040064, 10040065, 10040066, 10040067, 10040068, 10040069, 10040070, 10040071, 10040073, 10040074, 10040075, 10040076, 10040077, 10040078, 10400029, 10400050, 10400056, 10400057, 10400058, 10400059, 10400065, 10370016, 10370017, 10370018, 10370019, 10370020, 10370032, 10370033, 10370034, 10370035, 10370038, 10370052, 10370053, 10370054, 10370056, 10370060, 10370063, 10370078, 10370079, 10370080 , 09380031, 09380029, 09380064, 09380070, 09380089, 09380040, 09380038, 09380085, 09380045, 09380054, 09380060, 09380059, 09380058, 09380048, 09380042, 09380038, 09380069, 09380063, 09380067 & 09380065.", "firm_fei_number": "3007538326", "recalling_firm": "Primus Medical LLC", "address_1": "8401 Southern Blvd", "city": "Boardman", "state": "OH", "postal_code": "44512-6709", "additional_info_contact": "Mr. Mark R. Shaw\n330-965-9681", "reason_for_recall": "The \"Retaining washers & Clevis Pins\" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse.", "root_cause_description": "Equipment maintenance", "action": "The firm, Primus Medical LLC, sent an \"Important Notification Relating to Primus Medical Product TL500\" letter dated March 29, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to replace the \"Retaining washers & Clevis Pins\" with the \"Clevis Pins & Bow Tie Cotter Pins\" in the TL500-001 Service Pack provided with the letter in order to avoid any potential failure and/or bed collapse and to return the\" Retaining washers & Clevis Pins\" after the replacement procedure is performed. \n\nIf you have any questions, or need assistance in performing the replacement, call 330-965-9681.", "product_quantity": "342 Beds", "distribution_pattern": "Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.", "openfda": { "k_number": [ "K902183", "K925576", "K982783", "K951161", "K964246", "K853270", "K962942", "K872923", "K881965", "K911893", "K925534", "K881963", "K964515", "K946149", "K962763", "K881960", "K821185", "K202964", "K935837", "K900151", "K946208", "K894296", "K854937", "K851551", "K852674", "K872924", "K875037", "K974254", "K780371", "K972115", "K963589", "K930703", "K873291", "K934090", 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"device_class": "2" } } ] }