Events

Recall of Device Recall GE OEC 9900 Elite GSP fluoroscopic xray system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    50083
  • Event Risk Class
    Class 2
  • Event Number
    Z-0342-2009
  • Event Initiated Date
    2008-08-29
  • Event Date Posted
    2009-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74686
  • 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
    Fluoroscopic x-ray system - Product Code JAA
  • Reason
    Under certain conditions, x-ray system may experience operational impairment.
  • Action
    Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.

Device

Device Recall GE OEC 9900 Elite GSP fluoroscopic xray system
  • Model / Serial
    E2-0027, E2-0047-RC, E2-0067,  E2-0086, E2-0110, E2-0117,  E2-0136,  E2-0137,  E2-0162,  E2-0175,  E2-0194,  E2-0245, E2-0295, E2-0326,  E2-0334,  E2-0336,  E2-0339,  E2-0343,  E2-0344,  E2-0347,  E2-0350,  E2-0353, E2-0355,  E2-0356, E2-0358,  E2-0359,  E2-0362,  E2-0367,  E2-0374,  E2-0375,  E2-0382,  E2-0388,  E2-0395,  E2-0397,  E2-0411,  E2-0464,  E2-0476,  E2-0479,  E2-0480,  E2-0481,  E2-0487,  E2-0491,  E2-0500, and  E2-0501,  E9-0010,  E9-0011,  E9-0013,  E9-0019,  E9-0023,  E9-0026,  E9-0028, E9-0036-G,  E9-0039,  E9-0040-G,  E9-0045,  E9-0048,  E9-0049,  E9-0057, E9-0058,  E9-0063,  E9-0064,  E9-0067,  E9-0071,  E9-0078,  E9-0080,  E9-0081,  E9-0082,  E9-0083,  E9-0086,  E9-0088,  E9-0093,  E9-0115,  E9-0116, E9-0120,  E9-0123,  E9-0126,  E9-0130,  E9-0141,  E9-0143,  E9-0149,  E9-0153,  E9-0155,  E9-0156,  E9-0156,  E9-0157 E9-0158,  E9-0167,  E9-0180, E9-0181, E9-0184,  E9-0196,  E9-0202,  E9-0217,  E9-0221,  E9-0222,  E9-0223,  E9-0226,  E9-0227,  E9-0229,  E9-0230,  E9-0256,  E9-0259,  E9-0263,  E9-0269,  E9-0271,  E9-0272,  E9-0273,  E9-0274,  E9-0276,  E9-0278,  E9-0279,  E9-0281,  E9-0286,  E9-0287, E9-0288,  E9-0291,  E9-0293,  E9-0295,  E9-0296,  E9-0297,  E9-0298,  E9-0299,  E9-0302,  E9-0303,  E9-0304,  E9-0305,  E9-0308,  E9-0310,  E9-0311,  E9-0312,  E9-0315,  E9-0317,  E9-0318,  E9-0319,  E9-0320,  E9-0321,  E9-0322,  E9-0323,  E9-0324,  E9-0325,  E9-0326,  E9-0328,  E9-0330,  E9-0331,  E9-0333,  E9-0335,  E9-0336,  E9-0337,  E9-0338,  E9-0339,  E9-0340,  E9-0342,  E9-0343,  E9-0344,  E9-0345,  E9-0346,  E9-0347,  E9-0348,  E9-0349,  E9-0350,  E9-0351,  E9-0352,  E9-0355,  E9-0356,  E9-0358,  E9-0359,  E9-0360,  E9-0361,  E9-0362,  E9-0364,  E9-0365,  E9-0366,  E9-0367,  E9-0368,  E9-0369,  E9-0370,  E9-0371,  E9-0374,  E9-0376,  E9-0377,  E9-0378,  E9-0379,  E9-0380,  E9-0381,  E9-0382,  E9-0383,  E9-0385,  E9-0386,  E9-0387,  E9-0389,  E9-0392,  E9-0397,  E9-0399,  E9-0401,  E9-0402,  E9-0408,  E9-0409,  E9-0411,  E9-0412,  E9-0413,  E9-0414,  E9-0415,  E9-0418,  E9-0422,  E9-0423,  E9-0427,  E9-0428,  E9-0430,  E9-0431,  E9-0432,  E9-0433,  E9-0434,  E9-0435,  E9-0437,  E9-0438,  E9-0439,  E9-0440,  E9-0442,  E9-0451,  E9-0454,  E9-0455,  E9-0460,  E9-0467,  E9-0468,  E9-0469,  E9-0470,  E9-0473,  E9-0476, E9-0478,  E9-0480,  E9-0484,  E9-0485,  E9-0487,  E9-0489,  E9-0490,  E9-0491,  E9-0496,  E9-0500,  E9-0503,  E9-0508,  E9-0510,  E9-0512,  E9-0517,  E9-0518,  E9-0520,  E9-0521,  E9-0526,  E9-0528,  E9-0537,  E9-0538,  E9-0544,  E9-0549, and  E9-0009,  ES-0029-CH ES-0030,  ES-0037,  ES-0039,  ES-0048,  ES-0051,  ES-0057,  ES-0060-H,  ES-0064,  ES-0065,  ES-0066-CH ES-0073,  ES-0076,  ES-0089,  ES-0090,  ES-0096,  ES-0106,  ES-0108,  ES-0120,  ES-0121,  ES-0123,  ES-0124,  ES-0125,  ES-0126,  ES-0128,  ES-0135,  ES-0139,  ES-0147,  ES-0170,  ES-0172,  ES-0181, ES-0183,  ES-0187,  ES-0197,  ES-0208,  ES-0213,  ES-0214,  ES-0215,  ES-0221,  ES-0222,  ES-0223,  ES-0229,  ES-0230,  ES-0231,  ES-0232,  ES-0233,  ES-0235, ES-0237,  ES-0240,  ES-0241,  ES-0243,  ES-0244,  ES-0247,  ES-0248,  ES-0249,  ES-0250,  ES-0251, ES-0252,  ES-0256,  ES-0257,  ES-0258,  ES-0259,  ES-0260,  ES-0261,  ES-0263,  ES-0264,  ES-0265,  ES-0267,  ES-0268,  ES-0269,  ES-0270,  ES-0271,  ES-0276,  ES-0277,  ES-0278,  ES-0282,  ES-0283,  ES-0284,  ES-0285,  ES-0286,  ES-0287,  ES-0288,  ES-0289,  ES-0290,  ES-0291,  ES-0293,  ES-0294,  ES-0295,  ES-0296,  ES-0297,  ES-0298,  ES-0301,  ES-0302,  ES-0303,  ES-0304,  ES-0305,  ES-0306,  ES-0307,  ES-0308,  ES-0309,  ES-0310,  ES-0311,  ES-0313,  ES-0314,  ES-0315,  ES-0317,  ES-0318,  ES-0319,  ES-0320,  ES-0323,  ES-0324,  ES-0325,  ES-0327,  ES-0328,  ES-0329,  ES-0330,  ES-0331,  ES-0333,  ES-0334,  ES-0338,  ES-0339,  ES-0340,  ES-0341,  ES-0344,  ES-0345,  ES-0346,  ES-0347,  ES-0348,  ES-0350,  ES-0353,  ES-0356,  ES-0357,  ES-0361,  ES-0362,  ES-0368,  ES-0369,  ES-0370,  ES-0371,  ES-0372,  ES-0373,  ES-0386,  ES-0388,  ES-0389,  ES-0392,  ES-0393,  ES-0395,  ES-0396 ES-0397,  ES-0398,  ES-0406,  ES-0407,  ES-0408,  ES-0409,  ES-0410,  ES-0411,  ES-0414,  ES-0416,  ES-0420,  ES-0424,  ES-0426,  ES-0432,  ES-0440,  ES-0447,  ES-0448,  ES-0449,  ES-0453, ES-0457, ES-0466, ES-0470, ES-0471, ES-0473, ES-0474, ES-0475, ES-0477, ES-0481, ES-0489, ES-0491, ES-0492, ES-0503,  ES-0504, ES-0505, ES-0507, ES-0508, ES-0516,  ES-0517, ES-0519, ES-0520, ES-0530, ES-0531, ES-0537,  ES-0540, ES-0542, ES-0543, ES-0546, ES-0548, ES-7002-MH, and ES-7029-MH.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including AK, KY, NC, VA WA. and WI
  • Product Description
    GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
  • Manufacturer
    OEC Medical Systems, Inc

Manufacturer

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