{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Littleton",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79275",
      "recalling_firm": "Medtronic Navigation, Inc.-Littleton",
      "address_1": "300 Foster St",
      "address_2": "N/A",
      "postal_code": "01460-2017",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Puerto Rico. Distributed in Algeria, Australia, Chile, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Jordan, Lebanon, Sri Lanka, New Zealand, Nicaragua, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.",
      "recall_number": "Z-0928-2018",
      "product_description": "O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4) Model: BASE OARM Bl70000028230 SYS 230V, Product Number: Bl70000028230 (UDI: 00643169353992); (5) BASE OARM Bl70000028230R SYS 230V RWK, Product Number: Bl70000028230R (UDI: 00643169354081)     Product Usage:  The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm Imaging System is compatible with certain Image Guided Surgery Systems.",
      "product_quantity": "253",
      "reason_for_recall": "Software update (\"SW Update 3.2.1\") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.",
      "recall_initiation_date": "20180125",
      "center_classification_date": "20180308",
      "termination_date": "20190401",
      "report_date": "20180314",
      "code_info": "Serial Numbers: B14070845  B13050682  B13080716  B14010771  B14010779  B14020790  B14040813  B15020929  B14020789  B15101034  B15101041  B16011100  B16021102  B15060987  B14110904  B16021105  B16021106  B15020941  B15050972  B15030949  B16021111  B15091028  B14010774  B14030797  B16021112  B16031114  B16041137  B16061190  B15010926  B15060988  B16061196  B13080721  B16071207  B16071213  B13080722  B16071215  B16081234  B17101333  B14030803  B14040814  B17101445  B14040817  B17071466  B17121536  B14050830  B17121544  B14050829  B14070857  B14080865  B14090881  B13080718  B14050824  B14060833  B13060683  B13060698  B15030948  B15050971  B14010781  B14030802  B14030805  B15121072  B16011082  B13090723  B13120770  B14010772  B13120764  B14010776  B14030785  B14110898  B14120906  B14030807  B14050823  B14060832  B14060834  B16111259  B15020925  B15091014R  B17031257  B13080717  B14010775R  B15091020  B14040811  B14050822  B14070840  B15030946  B14030808  B13080724  B14070851  B14020773  B14120905  B14020794  B14080860  B15010922  B15020943  B15030951  B15060976  B15060984  B15070999  B15091023  B15091032  B14110897R  B14040810  O-Arm 831  O-arm 842  B14070854  B14090883  B14120909  B15010921  B15030954  B15091024  B15030952  B14080871  B14090872  B14090880  B14120908  B14120913  B15020928  B15030953  B15071004  B15091026  B15101039  B14080859  B15081008  B15091030  B15121049  B16011095  B14090873  B15111055  B15121064  B14080869  B14020786  B14070852  B14100887  B14110903  B14120917  B15010920  B15020927  B15020940  B14020792  B14100891  B14100893  B14120910  B15091018  B14020788  B14060836  B15040961  B16031115  B14040819  B14110899  B15040960  B15091019  B14090885  B15020942  B14050827  B14080867  B14070835  B15030955  B15040959  B14090882  B13120765  B14070846  B16051155  B14120915  B15071000  B14010777  B14090884  B14100886  B14100894  B14110902  B15050975  B16041138  B14110896  B15030950  B14010769  B14090863  B15121058  B13080720  O-arm 804  B14070839  B15020937  B15040958  B15091017  B14110901  B13120766  B14080862  B14080864  B14100895  B14120907  B14120912  B15010919  B15020939  B13120763  B13120768  B14020795  B14050826  B14070847  B14070849  B14080861  B14080866  B14100888  B15030947  B15060980  B15070992  B15081005  B15091012  B16031120  B16041136  B13090729  B14100889  B14100890  B17011287  B14120916  B13080715  B16081226  B16101239  B14010780  B16051159  B15030945  B14030796  B14040816  B14050821  B13050681  B13050685  B14030799  B15020938  B16041150  B14030800  B14090874  B14120911  B14030801  B14120918  B16031126  B15010923  B16061164  B14030787  B15050968  B14020793  B14030798  B14060838  B13080711  B13080719  B14030806  B15071003  B14050815  B15010924  B13070710  B14010782  B14020784  B14070843  B14010778  B14040812  B14040820  B14050828"
    }
  ]
}