{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Palo Alto",
      "address_1": "911 Hansen Way",
      "reason_for_recall": "Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].",
      "address_2": "",
      "product_quantity": "166 OSMS in US, 23 OSMO - International,",
      "code_info": "TrueBeam version 2.0/2.5 with any version OSMS.    OSMA serial numbers:  HOM0084  HOM0176  HOM0368  HOM0003  HOM0004  HOM0005  HOM0006  HOM0008  HOM0009  HOM0010  HOM0011  HOM0012  HOM0015  HOM0016  HOM0017  HOM0018  HOM0019  HOM0020  HOM0021  HOM0022  HOM0023  HOM0024  HOM0025  HOM0026  HOM0027  HOM0028  HOM0029  HOM0030  HOM0031  HOM0032  HOM0033  HOM0034  HOM0035  HOM0036  HOM0037  HOM0071  HOM0072  HOM0073  HOM0074  HOM0075  HOM0076  HOM0077  HOM0078  HOM0079  HOM0080  HOM0081  HOM0082  HOM0083  HOM0084  HOM0085  HOM0086  HOM0087  HOM0088  HOM0089  HOM0090  HOM0091  HOM0095  HOM0096  HOM0097  HOM0098  HOM0099  HOM0100  HOM0101  HOM0102  HOM0103  HOM0107  HOM0108  HOM0109  HOM0110  HOM0111  HOM0113  HOM0114  HOM0115  HOM0116  HOM0117  HOM0118  HOM0125  HOM0126  HOM0127  HOM0128  HOM0129  HOM0170  HOM0171  HOM0172  HOM0173  HOM0174  HOM0175  HOM0176  HOM0177  HOM0178  HOM0179  HOM0180  HOM0181  HOM0182  HOM0183  HOM0184  HOM0185  HOM0186  HOM0187  HOM0188  HOM0189  HOM0190  HOM0191  HOM0304  HOM0305  HOM0306  HOM0307  HOM0308  HOM0309  HOM0310  HOM0311  HOM0312  HOM0313  HOM0314  HOM0315  HOM0316  HOM0317  HOM0318  HOM0319  HOM0320  HOM0321  HOM0322  HOM0323  HOM0324  HOM0329  HOM0330  HOM0331  HOM0332  HOM0333  HOM0334  HOM0335  HOM0336  HOM0337  HOM0338  HOM0339  HOM0340  HOM0341  HOM0342  HOM0347  HOM0348  HOM0349  HOM0350  HOM0351  HOM0352  HOM0353  HOM0354  HOM0356  HOM0357  HOM0358  HOM0359  HOM0360  HOM0361  HOM0362  HOM0363  HOM0364  HOM0365  HOM0366  HOM0367  HOM0368  HOM0369  HOM0370  HOM0371  HOM0372  HOM0373  HOM0374  HOM0381  HOM0382  HOM0383  HOM0386  HOM0387  HOM0388  HOM0389  HOM0390  HOM0391  HOM0392  HOM0393  HOM0394  HOM0395  HOM0396  HOM0403  HOM0404  HOM0405  HOM0406  HOM0409  HOM0410  HOM0411  HOM0412  HOM0413  HOM0414  HOM0415  HOM0416  HOM0420  HOM0421  HOM0422  HOM0424  HOM0440  HOM0441  HOM0442  HOM0444  HOM0445  HOM0447  HOM0448  HOM0454  HOM0457  HOMWMZ1.",
      "center_classification_date": "20160711",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.",
      "state": "CA",
      "product_description": "Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE;    Radiology: The AlignRT Plus system is indicated for use to position  and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.",
      "report_date": "20160720",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Varian Medical Systems, Inc.",
      "recall_number": "Z-2149-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74585",
      "termination_date": "20180824",
      "more_code_info": "",
      "recall_initiation_date": "20160623",
      "postal_code": "94304-1028",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}