Events

Recall of MCT 100/480 ISOTRAN PLUS (AKA TEAL Power Conditioning Unit)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) 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
    44721
  • Event Risk Class
    Class 2
  • Event Number
    Z-1234-2007
  • Event Initiated Date
    2007-04-27
  • Event Date Posted
    2007-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64322
  • 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
    Power conditioner - Product Code JAK
  • Reason
    The teal power conditioning units may fail and result in the unit emitting fire and/or smoke. note: the teal power conditioning unit has the potential to fail when the scanner that is attached to the teal is powered and in use as well as when not in use.
  • Action
    On 9/04/2007, Philips Medical Systems (PMS) sent a letter via courier to all affected customers. The letter notified customers about the failures of the TEAL power conditioner and the possible emisson of fire and/or smoke from the units. In addition, the letter notes that PMS implemented a Field Change Order in May, 2007 that directs onsite repair of all affected units by PMS service technicians.

Device

MCT 100/480 ISOTRAN PLUS (AKA TEAL Power Conditioning Unit)
  • Model / Serial
    Part Number: 4450028-01; Serial Numbers: 73343, 74482, 74481, 74480, 74477, 74478, 74479, 74639, 74637, 74640, 74638, 74641, 74758, 79281, 79279, 79282, 79278, 79280, 79348, 79347, 79345, 79346, 79512, 79513, 79514, 79511, 79515, 79582, 79699, 79698, 79696, 79697, 79700, 79778, 79774, 79776, 79773, 79775, 79772, 79777, 79898, 79899, 79893, 79894, 79892, 79897, 79896, 79891, 79895, 79976, 79980, 79978, 79975, 79977, 79979, 79974, 80060, 80132, 80125, 80127, 80123, 80124, 80131, 80161, 80128, 80130, 80129, 80126, 80571, 80570, 80574, 80579, 80577, 80572, 80573, 80578, 80575, 80576, 80729, 80730, 80894, 80895, 80896, 80934, 80932, 80897, 80931, 80933, 80935, 80848, 81007, 81004, 81008, 81005, 81010, 81009, 81006, 81090, 81091, 81095, 81093, 81089, 81092, 91094, 746390.  Part Number 4450028-02; Serial Numbers: 80583, 81116, 81121, 81117, 81115, 81119, 81128, 81118, 81120, 81126, 81122, 81123, 81125, 81127, 81124, 81129, 81168, 81165, 81169, 81167, 81166, 81170, 81179, 81177, 81171, 81175, 81176, 81351, 81354, 81347, 81348, 81349, 81353, 81350, 81346, 81355, 81352, 81173, 81174, 81172, 81178, 81446, 81454, 81458, 81459, 81455, 81448, 81445, 81449, 81447, 81456, 81457, 81453, 81451, 81452, 81450, 81826, 81830, 81827, 81829, 81828, 81851, 81853, 81852, 81854, 81855, 82053, 82054, 82051, 82052, 82050, 82114, 82112, 82113, 82116, 82119, 82115, 82117, 82120, 82121, 82118, 82154, 82156, 82155, 82157, 82153, 82267, 82266, 82273, 82268, 82265, 82269, 82274, 82271, 82272, 82270, 82387, 82386, 82385, 82383, 82384, 82472, 82473, 82476, 82474, 82475, 82519, 82521, 82518, 82517, 82520, 82604, 82600, 82598, 82603, 82602, 82599, 82607, 82605, 82606, 82601, 82705, 82708, 82707, 82704, 82706, 82798, 82797, 82801, 82799, 82800, 82928, 82927, 82926, 82924, 82925, 83010, 83011, 83012, 83014, 83013, 83109, 83108, 83107, 83106, 83115, 83112, 83110, 83111, 83113, 83114, 83156, 83157, 83158, 83159, 83160, 83155, 83161, 83164, 83162, 83276, 83269, 83272, 83273, 83163, 83271, 83274, 83275, 83277, 83270, 83278, 83381, 83378, 83380, 83375, 83377, 83373, 83374, 83379, 83382, 83376, 73546, 83543, 83548, 83543, 83547, 83544, 83549, 83550, 83551, 83552, 83675, 83676, 83673, 83678, 83681, 83679, 83677, 83674, 83672, 83680, 83748, 83746, 83745, 83744, 83747, 83882, 83878, 83875, 83876, 83877, 83880, 83883, 83884, 83879, 83881, 83881, 83884, 83879, 83880, 83883, 84010, 84014, 84009, 84013, 84008, 84011, 84012, 84016, 84007, 84015, 84065, 84064, 84066, 84072, 84071, 84070, 84069, 84067, 84068, 84073, 84209, 84211, 84212, 84213, 84207, 84210, 84208, 84215, 84216, 84236, 84239, 84233, 84237, 84231, 84235, 84238, 84240, 84232, 84234, 83672, 84519, 84517, 84514, 84516, 84515, 84513, 83877, 83878, 84518, 84520, 84523, 84525, 84526, 84521, 84524, 84522, 84527, 84597, 84598, 84595, 84599, 84596, 84600, 84849, 84854, 84853, 84852, 84850, 84848, 84855, 84851, 84857, 84856, 85014, 85007, 85012, 85006, 85010, 85011, 85009, 85015, 85005, 85016, 85008, 85013, 85017, 85004, 85003, 83678, 85148, 85151, 85149, 85154, 85156, 85152, 85150, 85155, 85157, 85253, 85256, 85258, 85259, 85257, 85254, 85252, 85255, 85153, 85262, 85261, 85260, 85263, 85265, 85264, 85266, 85281, 85282, 85283, 85284, 85286, 85289, 85290, 85287, 85285, 85288, 85320, 85318, 85314, 85313, 85317, 85321, 85316, 85322, 85323, 85325, 85327, 85319, 85333, 85324, 85326, 85332, 85347, 85330, 85315, 85349, 85348, 85336, 85335, 85334, 85337, 85351, 85340, 85353, 85350, 85355, 85339, 85356, 85374, 85352, 85354, 85372, 85371, 85373, 85379, 85378, 85377, 85376, 85375, 85380, 85790, 85791, 85792, 85786, 85785, 85793, 85788, 85784, 85787, 85789.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including, USA, Canada, China, Italy, Russia, Brazil, Belgium, Germany, Austria, Australia, Netherlands, France, Korea, Denmark, Israel, England, Argentina, Mexico, Spain, Yemen, Greece, Egypt, Japan, UAE, & Chile.
  • Product Description
    The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** TEAL Electronics Corporation, San Diego, California ***".
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA