• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MCT 100/480 ISOTRAN PLUS (AKA TEAL Power Conditioning Unit)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
MCT 100/480 ISOTRAN PLUS (AKA TEAL Power Conditioning Unit)
see related information
Date Posted September 13, 2007
Recall Status1 Open
Recall Number Z-1234-2007
Recall Event ID 44721
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product 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 ***".
Code Information 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.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 491
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-