{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Montpellier",
      "state": "N/A",
      "country": "France",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88746",
      "recalling_firm": "MEDTECH SAS",
      "address_1": "900 Rue Du Mas De Verchant",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.",
      "recall_number": "Z-0118-2022",
      "product_description": "ROSA One 3.1 Brain application    The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.",
      "product_quantity": "119 (US); 55 (OUS)",
      "reason_for_recall": "The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.",
      "recall_initiation_date": "20210922",
      "center_classification_date": "20211025",
      "report_date": "20211103",
      "code_info": "Serial Numbers:    US:  BS16904  BS16905  BS16906  BS16909  BS16910  BS16911  BS16912  BS16913  BS16914  BS16915  BS16916  BS16917  BS16918  BS16921  BS16923  BS16925  BS17930  BS17934  BS17935  BS17936  BS17937  BS18900  BS18901  BS18924  BS18931  BS18938  BS18939  BS18940  BS18942  BS18943  BS18945  BS18946  BS18947  BS18948  BS18949  BS18950  BS18951  BS18952  BS18953  BS18954  BS18955  BS18956  BS18957  BS18958  BS18959  BS18960  BS18961  BS18962  BS18963  BS18964  BS18965  BS18966  BS18967  BS18968  BS18969  BS18970  BS18971  BS18972  BS18973  BS18974  BS18975  BS18976  BS18977  BS18979  BS18980  BS18981  BS18982  BS18983  BS18984  BS18985  BS18986  BS18987  BS18988  BS18989  BS18990  BS18991  BS18992  BS18993  BS18994  BS18995  BS18996  BS18997  BS18998  BS18999  BS19037  BS19038  BS19039  BS19040  BS19041  BS19043  BS19047  BS19049  BS19050  BS19052  BS19053  BS19054  BS19057  BS19058  BS19059  BS19060  BS19061  BS19065  BS20066  BS20067  BS20072  BS20073  BS20079  BS20080  BS20086  BS20092  BS20100  BS20103  BS20107  BS21112  BS21115  BS21121  BS21129  BS21137  BS21138    OUS:    BS15902  BS15903  BS16007  BS16919  BS16928  BS16929  BS17008  BS17010  BS17013  BS17021  BS17022  BS17023  BS18024  BS18026  BS18027  BS18028  BS18030  BS18031  BS19032  BS19033  BS19034  BS19035  BS19036  BS19042  BS19051  BS19056  BS19062  BS19064  BS20068  BS20069  BS20070  BS20071  BS20074  BS20075  BS20076  BS20077  BS20078  BS20082  BS20084  BS20085  BS20090  BS20095  BS20098  BS20099  BS20102  BS20105  BS20106  BS21108  BS21109  BS21114  BS21124  BS21128  BS21132  BS21133  BS21134"
    }
  ]
}