{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196360",
      "product_res_number": "Z-0221-2023",
      "event_date_initiated": "2022-10-14",
      "event_date_posted": "2022-11-11",
      "recall_status": "Open, Classified",
      "res_event_number": "90971",
      "product_code": "LPC",
      "pma_numbers": [
        "P910001S112"
      ],
      "product_description": "Philips Laser System, REF: LAS-100.  Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.",
      "code_info": "UDI-00813132027452, Software Version: 0.5.0.3, Serial Numbers: 100000, 100001, 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100033, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100120",
      "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": "719-633-8333",
      "reason_for_recall": "Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.",
      "root_cause_description": "Device Design",
      "action": "On 10/14/22, correction notices were mailed to customers who were asked to take the following actions:\n\nFirm recommends continued use of affected devices and to follow the operator's manual.  As a temporary mitigation, until software becomes available tentatively in Q2 2023, the user can perform steps when visually alerted on the system display as follows:\n\nError 106\nFirm's internal testing confirms that the following steps may temporarily resolve the issue, if encountered:\n1. System restart\n2. Recalibration of the catheter in use or calibration of a new catheter\n\nError 108\nFirm's internal testing confirms that the following steps will resolve the issue, if encountered:\n1. System restart\n2. Recalibration of the catheter in use or calibration of a new catheter\n3. Once the system is in the Ready State, pause 2 seconds before pressing the footswitch\n\nFirm recommends all affected device users within their facility are notified of correction and a copy of the correction notice should be retained.  Complete and return the Customer Reply Form. Tentatively in Q2 2023, firm will contact all affected customers and arrange for a Field Service Engineer to update the system software during preventive maintenance or service visits. Distributors are asked to send the notice and response form to customers to whom affected devices were distributed and to follow-up with these customers to obtain signed response forms.\n\nCustomers with additional questions are encouraged to call 1-800-231-0978 (option 1), Monday - Friday 9:00AM - 5:00PM MST, or email laserserviceops@phiIips.com",
      "product_quantity": "113",
      "distribution_pattern": "US: LA, MO, TN, CA, NC, PA, HI, AZ, CO, OK, FL, TX, MN, MI, VA, CT, NY, MD, IL, NJ, MA, KS, ME, AR, IA, IN, GA, ID, OR.\n\nOUS: DE, GB, ES, SE, IT, RS, GR, IN, FR, IL, DK, SA",
      "openfda": {
        "pma_number": [
          "P870071",
          "P870043",
          "P900032",
          "P910001"
        ],
        "registration_number": [
          "1721676",
          "1724474",
          "3007284006"
        ],
        "fei_number": [
          "1721676",
          "3003094851",
          "3007284006"
        ],
        "device_name": "Device, Angioplasty, Laser, Coronary",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}