Events

Recall of Series OEC 9800

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69474
  • Event Risk Class
    Class 2
  • Event Number
    Z-0195-2015
  • Event Initiated Date
    2014-10-03
  • Event Date Posted
    2014-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130741
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Ge healthcare initiated a field correction because prior revision of components were potentially installed on certain oec 9800, flexiview 8800, oec miniview 6800 and oec uroview 2800 systems.
  • Action
    On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Firm will track all service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.

Device

Series OEC 9800
  • Model / Serial
    Serial No: 82-0013,82-0045,82-0061,82-0071,82-0085,82-0122,82-0133,82-0190,82-0246,82-0357,82-0528,82-0533,82-0597,82-0626,82-0699,82-0702,82-0707,82-0718,82-0805,82-0818,82-0854,82-0855,82-0946,82-1040,82-1052,82-1062,82-1106,82-1133,82-1199,82-1292,82-1324,82-1348,82-1411,82-1453,82-1460,82-1526,82-1542,82-1608,82-1651,82-1658,82-1679,82-1709,82-1731,82-1773,82-1822,82-1867,82-1882,82-1905,82-1914,82-1979,82-2017,82-2018,82-2024,82-2030,82-2036,82-2049,82-2165,82-2169,82-2206,82-2225,82-2241,82-2279,82-2356,82-2388,82-2398,82-2454,82-2455,82-2459,82-2474,82-2535,82-2565,82-2603,82-2650,82-2655,82-2735,82-2751,82-2761,82-2767,82-2783,82-2851,82-2855,82-2909,82-2930,82-2945,82-2975,82-3003,82-3094,82-3096,82-3169,82-3210,82-3226,82-3232,82-3241,82-3319,82-3325,82-3377,82-3389,82-3395,82-3406,82-3424,82-3430,82-3456,82-3459,82-3500,82-3523,82-3534,82-3539,82-3569,82-3571,82-3629,82-3713,82-3748,82-3774,82-3826,82-3837,82-3851,82-3895,82-7048-MH,82-7066-MH,82-7103-MH,89-0028,89-0034,89-0037,89-0072,89-0105,89-0113,89-0135-RC,89-0184,89-0192,89-0308,89-0311,89-0316,89-0318,89-0388,89-0396,89-0427,89-0517,89-0586,89-0600,89-0623,89-0624,89-0642,89-0643,89-0743,89-0825,89-0827,89-0840,89-0843,89-0846,89-0866,89-0881,89-0894,89-0930,89-0947,89-0995,89-1023,89-1145,89-1157,89-1202,89-1204,89-1209,89-1260,89-1308,89-1327,89-1375,89-1392,89-1408,89-1411,89-1544,89-1652,89-1671,89-1698,89-1751,89-1804,89-1849,89-1868,89-1956,89-1964,89-1984,89-1986,89-2031,89-2050,89-2083,89-2085,89-2094,89-2118,89-2142,89-2170,89-2199,89-2244,89-2250,89-2336,89-2354,89-2459,89-2550,89-2555,89-2598,89-2623,89-2674,89-2682,89-2690,89-2695,89-2767,89-2777,89-2850,89-2862,89-2900,89-3031,89-3032,89-3124-N,89-3165,89-3171,89-3222,89-3252,89-3254,89-3311,89-3318,89-3346,89-3359,89-3367,89-3368,89-3419,89-3438,89-3531,8S-0014-C,8S-0026,8S-0029,8S-0058,8S-0059,8S-0070,8S-0113,8S-0162,8S-0224,8S-0232,8S-0389,8S-0467,8S-0511,8S-0529,8S-0531,8S-0549,8S-0605,8S-0755,8S-0766,8S-0782,8S-0858,8S-0876,8S-0933-C,8S-0997,8S-1000,8S-1015,8S-1147,8S-1165,8S-1166,8S-1192,8S-1427,8S-1447,8S-1509-C,8S-1565,8S-1585,8S-1897,8S-1907,8S-2008-N,8S-2053,8S-2062,8S-2092,8S-2103,8S-2107,8S-2232,8S-2234,8S-2268,8S-2310,8S-2385,8S-2408,8S-2432,8S-2445,8S-2471-C,8S-2491,8S-2530,8S-2543,8S-2550,8S-2554,8S-2564,8S-2618,8S-2650,8S-2651,8S-2671,8S-2675,8S-2695,8S-2701,8S-2734,8S-2746,8S-2770,8S-2792,8S-2798,8S-2819,8S-2835,8S-2861,8S-2862,8S-2914,8S-2922,8S-2984,8S-3004,8S-3048,8S-3055,8S-3088,8S-3143,8S-3162-H,8S-3219,8S-3272-H,8S-3289-H,8S-7102-MH,
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Series OEC 9800. || The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA