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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 65691
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems (Cleveland) Inc
City Cleveland
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-05
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norway, Poland, Romania, South Africa, South Korea, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom & Vietnam.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction. Model #, 728231, Serial #: 4021, 9535, 9544, 9587, 9627, 9701, 9707, 9713, 9759, 9875, 9887, 9917, 9925, 9931, 9980, 9996, 10009, 10011, 10012, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10152, 10153, 10154, 10162, 10165, 10166, 10170, 10171, 10172, 10173, 10188, 10189, 10191, 10196, 10198, 10203, 10214, 10222, 10227, 10228, 10229, 10230, 10235, 10238, 10242, 10243, 10247, 10259, 10260, 10261, 10263, 10268, 10273, 10274, 10278, 10288, 10291, 10293, 10294, 10297, 10298, 10301, 10302, 10307, 10312, 10313, 10316, 10317, 10318, 10319, 10320, 10327, 10336, 10337, 10341, 10347, 10349, 10350, 10351, 10352, 10353, 10362, 10365, 10376, 10380, 10384, 10387, 10393, 10400, 10411, 10412, 10414, 10431, 10438, 10439, 10445, 10446, 10452, 10453, 10459, 10461, 10468, 10470, 10471, 10476, 10482, 10486, 10490, 10491, 10503, 10511, 10513, 10519, 10535, 10536, 10540, 10544, 10546, 10551, 10554, 10561, 10563, 10568, 10569, 10574, 10582, 10600, 10617, 10628, 10631, 10635, 10646, 10647, 10651, 10655, 10659, 10673, 10684, 10686, 10698, 10714, 10733, 10734, 29002, 29014, 29016, 29027, 90054, 90099, 95022, 95046, 95073, 95103, 95107, 95109, 95114, 95132, 95133, 95181, 95209, 95268, 95295, 95305, 95371, 95453, 95473, 95563, 95660, 95704, 95706, 95707, 95712, 95715, 95721, 95727, 95729, 95769, 95778, 90199 & 95162. Model #, 728235, Serial #: 9034, 9190, 9233, 9234, 9261, 29049, 29057, 29064 & 29149. Model #, 728246, Serial #: 3150, 3163, 4051, 5547, 5585, 5623, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5791, 5803, 5813, 5836, 5855, 5862, 5868, 5876, 5877, 5897, 5911, 5916, 5935, 5969, 5971, 5974, 5997, 6001, 6006, 6008, 6028, 6087, 6102, 6117, 6120, 6121, 6126, 6170, 6195, 6200, 6202, 6203, 6238, 6243, 6281, 6287, 6306, 6318, 6324, 6346, 6352, 6387, 6402, 6405, 6444, 6484, 6491, 6494, 6495, 6496, 6503, 6517, 6519, 6523, 6556, 6559, 6609, 6610, 6611, 6612, 6623, 6624, 6640, 6642, 50115, 50147, 50166, 50180, 50189, 50193, 50195, 50197, 50198, 50204 & 50043. Model #, 728256, Serial #: 3490, 3500, 3679 & 3693. Class II The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch. M/N: 728256, 4 units; M/N: 728246, 89 units; M/N: 728235, 9 units & M/N: 728231, 207 units Z-2210-2013
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