{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "203278",
      "product_res_number": "Z-0290-2024",
      "event_date_initiated": "2023-10-12",
      "event_date_posted": "2023-11-09",
      "recall_status": "Open, Classified",
      "res_event_number": "93013",
      "product_code": "DTQ",
      "k_numbers": [
        "K133598"
      ],
      "product_description": "Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)",
      "code_info": "UDI-DI: 04058863074863;\nSerial Numbers: 90414355 through 90414868",
      "firm_fei_number": "3008355164",
      "recalling_firm": "Maquet Medical Systems USA",
      "address_1": "45 Barbour Pond Dr",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2094",
      "additional_info_contact": "Ms. Marylou Insinga\n973-709-7000",
      "reason_for_recall": "It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.",
      "root_cause_description": "Device Design",
      "action": "An URGENT MEDICAL DEVICE   Correction notification letter dated 10/12/23 was sent to customers.\n\nActions to be taken by the Customer:\nOur records indicate that you have received a CARDIOHELP-i System having a serial number\nthat is affected by this voluntary Medical Device Correction.\n\" Please examine your inventory immediately to determine if you have any affected\nCARDIOHELP System(s) in your inventory.\n\" Should you have any affected CARDIOHELP-i System(s), your unit(s) will need to be\nreturned to Getinge for correction. Getinge will contact your facility to arrange the return\nof your unit for correction. A CARDIOHELP loaner can be provided if needed.\n\" Please do not to fixate any accessory at the slide rail until the slide rail holders\nhave been replaced.\n\" Affected CARDIOHELP-i can be used for intra-hospital transport only when placed\non a Sprinter cart.\n\" Inter-hospital transport is not permitted until the slide rail holders have been\nreplaced.\n\" Please forward this information to all current and potential CARDIOHELP-i users\nwithin your hospital / facility.\n\" If you are a distributor who has shipped any affected products to customers, please\nforward this document to their attention for appropriate action.\n\" Whether or not your facility has affected product(s) listed in this notice, please complete\nand sign the attached MEDICAL DEVICE- CORRECTION RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Return the completed form to\nGetinge by e-mailing a scanned copy to Cardiohelpsliderail2023.act@getinge.com or by\nfaxing the form to 1-866-313-4049.\nType of Action by Getinge:\nA Getinge representative will contact you to arrange for the repair of your CARDIOHELP -i\nunit(s). Getinge will correct your CARDIOHELP -i unit(s) upon receipt and will return your unit(s)\nonce correction has been completed.\nThis voluntary correction only affects the products listed on Page 1; no other products are\naffected by this voluntary correction.\n\nWe apologize for",
      "product_quantity": "1022 units",
      "distribution_pattern": "US Nationwide.",
      "openfda": {
        "k_number": [
          "K842138",
          "K011088",
          "K052555",
          "K813034",
          "K863960",
          "K090006",
          "K822068",
          "K133598",
          "K021694",
          "K210130",
          "K861388",
          "K002116",
          "K071318",
          "K173834",
          "K943803",
          "K871131",
          "K221373",
          "K862973",
          "K851615",
          "K080832",
          "K870976",
          "K801097",
          "K915183",
          "K151349",
          "K060053",
          "K092463",
          "K190282",
          "K030141",
          "K070213",
          "K091007",
          "K020571",
          "K163531",
          "K772001",
          "K062396",
          "K103762",
          "K002118",
          "K863541",
          "K982014",
          "K102726",
          "K022947",
          "K942582",
          "K770002",
          "K232291",
          "K153376",
          "K221895",
          "K964017",
          "K202125",
          "K950990",
          "K172220",
          "K131041",
          "K851614",
          "K093882"
        ],
        "registration_number": [
          "2916596",
          "9680841",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "2184009",
          "1218444",
          "8010762",
          "9611109",
          "3019807891",
          "3006073153",
          "3002807090",
          "3010703925",
          "3009507273",
          "3005941719",
          "3011554160",
          "3001589655"
        ],
        "fei_number": [
          "2916596",
          "1000116158",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "1218444",
          "3002808267",
          "3019807891",
          "3006073153",
          "3010703925",
          "3009649876",
          "3006003617",
          "3002807111",
          "3009507273",
          "3011554160",
          "3001589655",
          "3005426550"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}