{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "193099", "product_res_number": "Z-1078-2022", "event_date_initiated": "2022-04-01", "event_date_created": "2022-05-13", "recall_status": "Open, Classified", "res_event_number": "89998", "product_code": "MEC", "product_description": "Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.", "code_info": "UDI Codes: [07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078.] Serial Numbers: WAA088008, WAA088276, WAA089054, WAA089188, WAA089511, WAA091312, WAA092134, WAA097871, WAA098978, WAA087395, WAA087675, WAA087676, WAA088563, WAA088677, WAA088684, WAA088798, WAA088973, WAA090326, WAA090827, WAA090829, WAA091562, WAA092656, WAA092905, WAA093809, WAA094122, WAA094447, WAA095653, WAA095654, WAA095655, WAA096084, WAA096723, WAA096820, WAA099698, WAA100249, WAA100596, WAA100828, WAA102416, WAA102300, WAA102301, WAA086373, WAA088830, WAA089854, WAA089735, WAA089736, WAA090141, WAA090273, WAA090274, WAA091427, WAA093786, WAA094342, WAA095013, WAA095014, WAA096724, WAA098589, WAA099164, WAA098725, WAA100514, WAA100695, WAA100704, WAA100832, WAA101375, WAA100834, WAA101893, WAA076270, WAA085559, WAA086376, WAA086914, WAA086915, WAA088007, WAA088273, WAA088464, WAA088465, WAA087754, WAA088678, WAA088685, WAA088871, WAA088998, WAA089258, WAA089356, WAA089446, WAA089970, WAA089969, WAA090495, WAA090615, WAA090746, WAA091561, WAA091184, WAA091560, WAA091563, WAA091564, WAA091869, WAA091870, WAA091873, WAA091868, WAA092136, WAA091872, WAA092904, WAA093646, WAA093882, WAA093967, WAA094123, WAA094202, WAA094284, WAA094285, WAA094286, WAA094617, WAA094601, WAA095421, WAA096425, WAA096427, WAA096428, WAA097298, WAA098056, WAA099694, WAA099450, WAA099451, WAA099695, WAA099697, WAA100127, WAA100826, WAA100827, WAA100830, WAA101342, WAA101894, WAA103173, WAA088274, WAA093968", "firm_fei_number": "3013876692", "recalling_firm": "Getinge Usa Sales Inc", "address_1": "1 Geoffrey Way", "city": "Wayne", "state": "NJ", "postal_code": "07470-2035", "additional_info_contact": "Ms. Marylou Insinga\n973-709-7442", "reason_for_recall": "Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.", "root_cause_description": "Other", "action": "An Urgent Medical Device Notification was issued 04/01/2022 via FedEx which includes serial numbers for affected devices. Customers are to verify they have an affected device and submit the attached Response Form. Distributors are to forward notification on to customers. Getinge service technicians will contact customers to schedule corrective actions. You can continue to use the Getinge Series 9100E-series Washer Disinfector with G1 control systems until the corrective action is performed, there are no precautionary actions necessary. Contact your Getinge representative with questions or for Technical Support call (888) 943-8872 (options 4,2,1), Monday through Friday, 8:00 a.m. - 6:00 p.m EST, or email techsupportIC.us@getinge.com.", "product_quantity": "127", "distribution_pattern": "Worldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV. (OUS) Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Kuwait, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.", "openfda": { "registration_number": [ "8043629", "9616031", "9617134", "3021244152", "3015136927", "3027509245", "3012006473", "1825014", "3005273623", "3011554142", "3030733800", "3006446479", "3010834934", "3018520804", "3030536467", "8021896", "3043861826", "3006654680", "2225311", "3012776156", "3022516928", "3008344687", "3017293064", "3010392991", "3031563141", "3001061128", "1056339", "3042250638", "9680353", "3006563173", "3029300415", "3017847344", "3005544459", "3002821232", "3021233712", "3030516433", "3010653034", "3010208143", "3015977541", "9680101" ], "fei_number": [ "3021244152", "3015136927", "3027509245", "3012006473", "1825014", "3004097451", "3005273623", "3011554142", "3030733800", "3006446479", "3010834934", "3018520804", "3000255542", "3030536467", "3043861826", "3006654680", "3002806590", "2225311", "3012776156", "3022516928", "3008344687", "3017293064", "3010392991", "3031563141", "1000140463", "3008241044", "3001061128", "3042250638", "3006563173", "3029300415", "3001168737", "3017847344", "3000231474", "3002821232", "3021233712", "3030516433", "3010653034", "1000273801", "3010208143", "3015977541" ], "device_name": "Disinfector, Medical Devices", "medical_specialty_description": "General Hospital", "regulation_number": "880.6992", "device_class": "2", "k_number": [ "K911120", "K081094" ] } } ] }