Events

Recall of Monitor Ceiling Suspension

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Sales & Service Region No. America.

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
    27477
  • Event Risk Class
    Class 2
  • Event Number
    Z-0097-04
  • Event Initiated Date
    2003-10-10
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29932
  • 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
    System, X-Ray, Angiographic - Product Code IZI
  • Reason
    The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
  • Action
    The firm issued a letter dated October 10, 2003 to all affected customers. The suspension will be upgraded by field service personnel starting October 24, 2003.

Device

Monitor Ceiling Suspension
  • Model / Serial
    Part Numbers: 9807 605 71009, 9896 000 36771, 9896 000 36772. The firm uses site numbers as their serial numbers. Site Numbers: 76808, 6838, 35445, 38929, 62374, 41372, 74032, 17656, 44744, 50026, 44772, 38922, X0346, X0934, 41111, 38993, 6981, 6842, 59515, 6852, 6853, 44760, 67565, 62392, 74007, 44299, 44337, 41000, 25923, 35484, 37878, 6498, 44328, 41378, 45039, 41426, 62003, 37932, 13879, 25750, 41031, 76213, 62666, 62667, 76329, 44898, 41156, 37907, 38944, 45042, X0344, 38912, 40941, 46931, 62885, 13721, X0855, 6931, 46926, X1078, 47033, 44593, 100014, X1077, 76804, 44865, 13918, X0917, 76449, 74026, 6937, 6648, 25945, 35403, 25987, 35471, 73522, 47160, X1207, 50317, 47128, 6539, 76085, 17436, 59524, 47166, 17605, 50251, 76388, 47060, 26071, 73908, 62502, 62504, 62444, 67609, 67597, 67610, 37872, 37874, 62304, 6820, 44825, 41128, 62377, 73428, 13317, 61871, 41109, 26108, 26118, 41360, 6552, 26063, 59610, 59611, 37879, 37937, 37992, 73793, 25773, 25908, 26038, 26039, X0483, 35593, 67580, 37880, 45026, 62376, 6738, 35500, X0672, X0078, 16712, 16713, X0042, 16690, 17382, 17492, 76465, 46879, 35473, 62385, 59423, 13731, 50152, X0404, 35153, 67221, 67225, 68028, 68044, 68159, 67428, 59295, 59377, 13310, 62289, 59279, 59302, 59380, 47138, 50091, 6601, 6784, 6785, 37959, 6739, 67811, 37924, 34685, 35356, 59249, 59255, 17457, 17458, 67277, 68100, 45051, 46423, 34808, 40161, 47117, 47171, 13617, X0036, X0939, 34659, 41163, 41164, 25699, 52396, 52131, 59296, 61970, 31023, 35303, 25809, 35310, 40271, 46468, 43914, 41026, 62505, 25725, 62390, 73865, 74046, 59551, 17474, 62940, 37910, 38986, 67334, 67992, 62636, 62638, 38554, 59360, 61892, 15207, 62317, 13502, X0041, 6591, 25952, 41017, 59188, 67279, X0402, 76148, 62315, 62335, 6654, 25999, 25965, 25973, 15215, 74080, X0063, 25935, 25948, 25706, 25666, 25895, 50180, 62483, 62314, 38916, 35217, 13492, 25886, 59237, 59364, 46928, 13482, 73423, 73912, 15186, 50025, 67129, 76076, X0501, X1275, X1345, 4295, 6090, 6236, 6410, 46068, 58460, 59111, X0978, X1164, 104853, 67628, 73896, 62649, 62967, 46961, X0398, X0400, X0406, X0407, X0410, X0503, X0510, X0621, X0669, X0670, X0754, X0838, X0846, 62340, 73878, 49677, X0789, 67587, 61976, 34728, X0044, 25909, 59276, 46633, X1185, 59396, 44671, 73498, 41242, 44689, 35364, 104480, 25998, 62999, 47089, 26062, 16757, 44697, 17264, 13633, 13639, 37837, 44609, 59391, 25964, 37877, 37988, 13383, 13599, 44791, 17453, 25835, 25836, 25838, 13562, 6733, 76342, 6609, 6610, X0093, 37970, 26061, 59231, 25950, 73988, 44323, 40007, 73880, 35229, 62339, 38080, 25917, 6821, 44623, 13519, 10414, 25849, 6656, 6869, 59527, 74012, 76084, 44826, 44288, 44740, 62521, 13503, 25842, 34699, 44698, 52339, 59368, 62435, 62436, 67354, 47169, 47140, 62268, 26109, 6803, 40127, 44848, 50130, 59139, 59218, 59346, 13605, 6671, 59301, 73908, 68098, 17528, 35489, 62346, 74053, 50103, 61941, 67336
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributes to hospitals and medical centers.
  • Product Description
    Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Manufacturer Address
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA