{
  "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": "Cambridge",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87732",
      "recalling_firm": "Philips North America Llc",
      "address_1": "222 Jacobs St",
      "address_2": "N/A",
      "postal_code": "02141-2289",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide  Foreign:  Argentina  Australia  Austria  Bangladesh  Belgium  Bulgaria  Canada  Chile  China  Croatia  Cyprus  Czech Republic  Denmark  Dominican Republic  Ecuador  Egypt  Estonia  Finland  France  Germany  Greece  Hungary  Iceland  India  Indonesia  Iran  Iraq  Ireland  Israel  Italy  Jordan  Kazakhstan  Kenya  Korea, Republic of  Kuwait  Latvia  Lebanon  Libya  Lithuania  Malaysia  Mauritius  Mexico  Mongolia  Morocco  Myanmar  Nepal  Netherlands  New Caledonia  New Zealand  Nigeria  Norway  Oman  Pakistan  Palestine, State of  Panama  Peru  Philippines  Poland  Portugal  Puerto Rico  R¿union  Romania  Russian Federation  Saudi Arabia  Serbia  Singapore  Slovenia  South Africa  Spain  Sri Lanka  Sweden  Switzerland  Syrian Arab Republic  Taiwan  Thailand  Tunisia  Turkey  United Arab Emirates  United Kingdom  Uzbekistan  Viet Nam  Yemen",
      "recall_number": "Z-1517-2021",
      "product_description": "Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring    Service numbers associated with FC2010:  Xper Flex Cardio 2010 Rev A 453564241901  Xper Flex Cardio 2010 Rev B 453564483321  Flex Cardio FC2010 Rev C 453564621791  Xper Flex Cardio 2010 REV C RUEXCHANGE 453564675021  Xper Flex Cardio 2010 Rev D 453564669081  Xper Flex Cardio 2010 Rev D Russia 453564674581  Xper Flex Cardio FC2010 Rev E 453564845841  Xper Flex Cardio 2010 Rev E Russia 453564845881     Service numbers associated with FC2020:  Xper Flex Cardio 2020 Rev A 453564241911  Xper Flex Cardio 2020 Rev B 453564483331  Flex Cardio FC2020 Rev C 453564621801  Xper Flex Cardio 2020 Rev D 453564675001  Xper Flex Cardio FC2020 Rev E 453564845861    Software version number: 1.5.19 and 1.6.8",
      "product_quantity": "9208 units WW",
      "reason_for_recall": "Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric  values cease to update;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform,  erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor",
      "recall_initiation_date": "20210329",
      "center_classification_date": "20210429",
      "report_date": "20210505",
      "code_info": "Service Number/ UDI #  453564241901    (01)00884838082113;  453564241911    (01)00884838082113;  453564483321    (01)00884838082113;  453564483331    (01)00884838083516;  453564621791    (01)00884838084902;  453564621801    (01)00884838084919;  453564845881    (01)00884838095052;  453564675021    (01)00884838103245;  453564669081    (01)00884838083820;  453564675001    (01)00884838086005;  453564674581    (01)00884838083820;  453564845841    (01)00884838093645;  453564845861    (01)00884838093652",
      "more_code_info": ""
    }
  ]
}