Z-1480-2017 Class II Terminated
FDA device recall Z-1480-2017 was initiated by Philips Medical Systems (Cleveland) Inc on January 31, 2017 and is designated Class II. Reason for recall: Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unloa… The recall status is terminated (terminated July 2, 2018). Affected quantity: 1218 total.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- January 31, 2017
- Termination Date
- July 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1218 total
Product Description
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
Reason for Recall
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
Distribution Pattern
Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, & VIETNAM.
Code Information
4000201, 40007030003, 40007060006, 4000586, 4000327, 4000307, 4000361, 4000146, 4000159, 4000077, 4000050, 4000687, 4000325, 4000165, 4000252, 4000315, 4000191, 4000598, 4000141, 4000565, 4000135, 4000537, 4000591, 4000311, 4000626, 4000636, 4000329, 4000181, 4000644, 4000171, 4000120, 4000484A, 4000441, 4000054, 4000110, 4000653, 4000590, 4000100, 4000520, 4000323, 4000403, 4000406, 4000489, 4000277, 4000306, 4000332, 4000635, 4000270, 4000302, 4000046, 4000214, 4000615, 4000187, 4000660, 4000383, 4000633, 4000322, 4000212, 4000628, 4000034, 4000232, 4000668, 4000480, 4000430, 4000553, 4000467, 4000221, 4000127, 4000259, 4000670, 4000193, 4000222, 4000289, 4000597, 4000439, 4000542, 4000531, 4000588, 4000358, 4000330, 4000508, 4000310, 4000371, 4000501, 4000609, 4000616, 4000116, 4000452, 4000058, 4000521, 4000059, 4000064, 4000482, 4000384, 4000528, 4000177, 4000506, 4000278, 4000089, 4000139, 4000130, 4000564, 4000578, 4000674, 4000083, 4000583, 4000225, 4000267, 4000563, 4000587, 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4000645, 4000035, 4000219, 4000485, 4000643, 4000376, 4000416, 4000243, 4000437, 4000694, 4000551, 4340004, 4000272, 4000478, 4000296, 4000354, 4000493, 4000072, 4000237, 4000107, 4000227, 4000105, 4000698, 4000333, 4000339, 4000385, 4000109, 4000115, 4000356, 4000257, 4000173, 4000126, 4000121, 4000494, 4000398, 4000503, 4000386, 4000399, 4000179, 4000600, 4000400, 4000397, 4000194, 4000154, 4000504, 4000233, 4000256, 4000667, 4000401, 4000394, 4000585, 4000168, 4000631, 4000268, 4000382, 4000692, 4000693, 4000337, 4000595, 4000447, 4000273, 4000169, 4000442, 4000412, 4000488, 4000297, 4000228, 4000156, 4000047, 4000049, 4000096, 4000281, 4000288, 4000484, 4340005, 10422, 4000419, 4000462, 4000463, 4000464, 4000638, 4000390, 4000348, 4000613, 4000655, 4000286, 4000294, 4000395, 4000672, 4000057-OLD, 4000389, 4000290, 4000283, 4000312, 4000328, 4000375, 4000560, 4000366, 4000417, 4000051, 4000372, 4000151, 4000422, 4000195, 4000088, 4000381, 4000071, 4000003, 4000549, 4000487, 4000056, 4000006, 4000466, 4000550, 4000346, 4000683, 4000483, 4000301, 4000158, 4000223, 4000045, 4000129, 4000057, 4000557, 4000567, 4000370, 4000536, 4000029, 4000607, 4000067, 4000068, 4000032, 4000423, 4000039, 4000031, 4000620, 4000678, 4000601, 4000122, 4000647, 4000341, 4000316, 4000342, 4000408, 4000421, 4000495, 4000511, 4000664, 4000317, 4000338, 4000604, 4000682, 4000540, 4000137, 4000343, 4000030, 4000379, 4000451, 4000533, 4000602, 4000472A, 4000581, 4000469, 4000648, 4000510, 4000454, 4000335, 4000436, 4000353, 4000418, 4000491, 4000571, 4000197, 4000555, 4000518, 4000544, 4000500, 4000592, 4000617, 4000012, 4000213, 4000413, 4000699, 4000218, 4000123, 4000287, 4000070, 4000166, 4000202, 4000102, 4000276, 4000091, 4000301-1, 4000455, 4000033, 4000364, 4000008, 4000497, 4000498, 4000681, 4000009, 4000184, 4000554, 4000516, 4000303, 4000576, 4000190, 4000305, 4000411, 4000669, 4000614, 4000324, 4000612, 4000566, 4000627, 4000552, 4000280, 4000378, 4000336, 4000559, 4000229, 4000262, 4000298, 4000043, 400000275, 4000044, 4000065, 4000061, 4000180, 4000224, 4000321, 4000081, 4000410, 4000651, 4000652, 4000665, 4000688 & 5000916,