—#64322

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 ***".

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-04-27
Posted by FDA: 2007-09-13
Terminated: 2012-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64322. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.