Events

Recall of Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

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
    48992
  • Event Risk Class
    Class 2
  • Event Number
    Z-2210-2010
  • Event Initiated Date
    2008-06-26
  • Event Date Posted
    2010-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72469
  • 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
    Motorized Height Ceiling Suspension - Product Code IZI
  • Reason
    Monitor ceiling carriage may separate from the monitor ceiling suspension.
  • Action
    On 07/02/08, the firm sent a "Urgent - Device Correction" letter to all their consignees. The letter describes a product as X-Ray system with Monitor Ceiling Suspension and motorized height movement. The consignees are informed that the fixation bolts supporting the monitor ceiling carriage may come loose creating a situation which may allow the monitor ceiling carriage to separate from motorized height Monitor Ceiling Suspension and that would cause serious injury to patient and user. The firm has issued a mandatory Field Correction Action to correct the problem and the firm's technicians will inspect all ceiling suspension actuators for loose screws. If loose screws are found the actuator will be replaced. Consignees should call Philips Call Center at 800-722-9377 #5, #4, #1, and Reference FCO72200126.

Device

Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems
  • Model / Serial
    Products are identified as Equipment numbers:  13046, 25934, 34702, 38592, 41455, 44791, 45059, 52463, 62671, 82824, 83667, 85095, 85137, 85190, 85195, 86189, 86341, 86575, 86914, 86981, 87359, 87364, 100788, 101036, 101077, 101612, 101952, 102664, 103147, 103238, 103265, 103270, 103281, 103283, 103380, 103525, 103526, 103562, 103564, 103781, 103891, 104075, 104076, 104077, 104149, 104464, 104497, 104670, 104950, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 105073, 105139, 105140, 105304, 105489, 105598, 105670, 105674, 105779, 105953, 105960, 203880, 215045, 215140, 500038, 504493, 504655, 504666, 504674, 504733, 504742, 504747, 504776, 504779, 505064, 505077, 505111, 505111, 505252, 505271, 505281, 505363, 505421, 505486, 505530, 505538, 505650, 505809, 505858, 505860, 505861, 505876, 505968, 506026, 506049, 506069, 506119, 506169, 506469, 506509, 506538, 506539, 506540, 506541, 506564, 506616, 506621, 506637, 506778, 519115, 519118, 519136, 519195, 519196, 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540284, 540288, 540301, 540311, 540312, 540317, 540321, 540325, 540338, 540374, 540386, 540421, 540456, 540460, 540461, 540487, 540622, 540684, 540721, 540790, 540808, 540841, 540887, 540912, 540930, 540952, 540973, 541026, 541029, 541030, 541046, 541049, 541053, 541080, 541223, 541237, 541238, 541239, 541251, 541253, 541259, 541276, 541509, 541510, 541572, 541577, 541588, 541589, 541590, 541592, 541597, 541657, 541659, 541667, 541715, 541742, 541748, 541783, 541822, 541848, 541873, 541880, 542109, 542113, 542117, 542306, 542382, 542413, 542478, 542486, 542518, 542522, 542526, 542557, 542714, 542744, 542963, 543087, 543194, 543200, 543209, 543213, 543216, 543229, 543289, 543386, 543397, 543398, 543399, 543411, 543444, 543610, 543611, 543690, 543702, 543759, 543762, 543799, 543829, 543850, 543873, 543877, 543879, 543931, 543953, 543971, 543972, 543984, 543988, 543989, 543999, 544005, 544048, 544051, 544052, 544057, 544086, 544103, 544120, 544122, 544130, 544145, 544184, 544306, 544371, 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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States and Canada.
  • Product Description
    Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. || Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA