{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194234",
      "product_res_number": "Z-1351-2022",
      "event_date_initiated": "2022-06-01",
      "event_date_created": "2022-07-11",
      "recall_status": "Open, Classified",
      "res_event_number": "90364",
      "product_code": "LPC",
      "pma_numbers": [
        "P910001S115"
      ],
      "product_description": "Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM",
      "code_info": "Serial Numbers: 100000  to 100104\nUDI/DI: (01)00813132027452",
      "firm_fei_number": "3007284006",
      "recalling_firm": "Spectranetics Corporation",
      "address_1": "9965 Federal Dr",
      "city": "Colorado Springs",
      "state": "CO",
      "postal_code": "80921-3822",
      "additional_info_contact": "Emily Dentler\n619-380-1318",
      "reason_for_recall": "The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.",
      "root_cause_description": "Device Design",
      "action": "On June 08, 2022 Spectranetics issued a \"Urgent Medical Device Correction\" notification to affected consignees via USPS. The recall notification asked consignees to take the following actions: \n\n1. Philips internal testing confirms that 1-3 reboots of the system will temporarily resolve the issue. Philips also recommends the continued use of the Philips Laser System, and to follow the Operator s Manual, as there is no\nexpected harm to the user or patient.\n\nPhilips recommends notifying all Philips Laser System users within your facility of this communication and retain a copy of this letter for reference. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form, included with this letter, within 30 days upon receipt of this notice to the following\nEmail: igtdc.r@philips.com\n\nIf you are a distributor or have forwarded affected device(s) to another end user, it is imperative that all end-users with affected devices receive this URGENT Medical Device Correction. Therefore, send a copy of this notification to any customer to whom you have distributed the affected product. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips IGTD \n\nCustomer Service:\nPhilips Laser System (PLS) Customer Service:\nPhone: 1-800-231-0978\nEmail: laserserviceops@philips.com\nHours of Operation: Monday - Friday 9:00AM   5:00PM MST",
      "product_quantity": "105 units",
      "distribution_pattern": "US: AR\tAZ\tCA\tCO\tCT\tFL\tGA\tHI\tIA\tIL\tIN\tKS\tLA\tMA\tMD\tME\tMI\tMN\tMO\tNC\tNJ\tNY\tOK\tPA\tTN\tTX\tVA\n\nOUS: Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom",
      "openfda": {
        "pma_number": [
          "P900032",
          "P870071",
          "P870043",
          "P910001"
        ],
        "registration_number": [
          "3007284006",
          "1724474",
          "1721676"
        ],
        "fei_number": [
          "3007284006",
          "3003094851",
          "1721676"
        ],
        "device_name": "Device, Angioplasty, Laser, Coronary",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}