{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Cambridge",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98779",
      "recalling_firm": "Philips North America",
      "address_1": "222 Jacobs St",
      "address_2": "",
      "postal_code": "02141-2296",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.",
      "recall_number": "Z-1958-2026",
      "product_description": "Philips Ingenia 3.0T with MR Elastography (MRE).     1. Model Number (REF): 781342.     2. Model Number (REF): 781377.     3. Model Number (REF): 782103.     510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808",
      "product_quantity": "64 units",
      "reason_for_recall": "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.",
      "recall_initiation_date": "20260414",
      "center_classification_date": "20260427",
      "report_date": "20260506",
      "code_info": "1. Model Number (REF): 781342. UDI: (01)00884838055339(21)71693, (01)00884838055339(21)71581, (01)00884838055339(21)71582, (01)00884838055339(21)71607, (01)00884838055339(21)85216, (01)00884838055339(21)71106, (01)00884838055339(21)71477, (01)00884838055339(21)71512, (01)00884838055339(21)71966, (01)00884838055339(21)71967, (01)00884838055339(21)85147, (01)00884838055339(21)85224, (01)00884838055339(21)85318, (01)00884838055339(21)71462, (01)00884838055339(21)71619, (01)00884838055339(21)85250, (01)00884838055339(21)71002, (01)00884838055339(21)71037, (01)00884838055339(21)71269, (01)00884838055339(21)71841, (01)00884838055339(21)71885, (01)00884838055339(21)71897, (01)00884838055339(21)85126, (01)00884838055339(21)85109, (01)00884838055339(21)71296, (01)00884838055339(21)71188, (01)00884838055339(21)71088, (01)00884838055339(21)71387, (01)00884838055339(21)71799, (01)00884838055339(21)71040, (01)00884838055339(21)71344, (01)00884838055339(21)71583, (01)00884838055339(21)71916, (01)00884838055339(21)71368, (01)00884838055339(21)71756, (01)00884838055339(21)71822, (01)00884838055339(21)71459, (01)00884838055339(21)71022, (01)00884838055339(21)71185, (01)00884838055339(21)71286, (01)00884838055339(21)71378, (01)00884838055339(21)71646, (01)00884838055339(21)71732, (01)00884838055339(21)71612, (01)00884838055339(21)71340, (01)00884838055339(21)71336. Serial Numbers: 71693, 71581, 71582, 71607, 85216, 71106, 71477, 71512, 71966, 71967, 85147, 85224, 85318, 71462, 71619, 85250, 71002, 71037, 71269, 71841, 71885, 71897, 85126, 85109, 71296, 71188, 71088, 71387, 71799, 71040, 71344, 71583, 71916, 71368, 71756, 71822, 71459, 71022, 71185, 71286, 71378, 71646, 71732, 71612, 71340, 71336.   2. Model Number (REF): 781377. UDI: (01)00884838009813(21)42305, (01)00884838009813(21)42097, (01)00884838009813(21)42364, (01)00884838009813(21)42136, (01)00884838009813(21)42237, (01)00884838009813(21)42455, (01)00884838009813(21)42087, (01)00884838009813(21)42401, (01)00884838009813(21)42321, (01)00884838009813(21)42001, (01)00884838009813(21)42036, (01)00884838009813(21)42053, (01)00884838009813(21)42126, (01)00884838009813(21)42400. Serial Numbers: 42305, 42097, 42364, 42136, 42237, 42455, 42087, 42401, 42321, 42001, 42036, 42053, 42126, 42400.   3. Model Number (REF): 782103. UDI: (01)00884838098299(21)85672, (01)00884838098299(21)85673, (01)00884838098299(21)85674, (01)00884838098299(21)85646. Serial Numbers: 85672, 85673, 85674, 85646.",
      "more_code_info": ""
    }
  ]
}