Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The device is a diagnostic x-ray beam-limiting device intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- February 7, 2008
- Posted
- September 16, 2008
- Terminated
- March 8, 2011
- Recall Number
- Z-1886-2008
- Quantity
- 709 devices
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.
Distribution
Units were distributed nationwide to medical centers and hospitals, including military and VA hospitals.
Lot / Code Info
Site numbers: 6544, 10029, 10033, 10417, 10419, 10434, 10461, 10481, 10498, 10499, 13012, 13028, 13032, 13034, 13122, 13125, 13131, 13146, 13198, 13216, 13224, 13225, 13243, 13244, 13246, 13247, 13248, 13249, 13250, 13251, 13252, 13254, 13256, 13278, 13279, 13285, 13295, 13295, 13912, 14078, 14081, 14176, 26155, 38193, 38194, 38197, 38281, 38299, 38319, 38350, 38354, 38367, 38446, 38609, 38633, 38667, 38684, 38747, 38875, 38959, 38960, 38989, 40934, 40934, 41237, 41353, 41408, 41464, 41469, 41471, 41472, 41473, 45034, 50386, 50448, 52452, 52453, 52454, 52457, 52458, 52458, 52474, 76579, 76586, 76829, 76891, 76894, 76905, 76906, 76907, 76907, 76908, 76909, 76920, 76921, 76922, 76926, 76943, 76949, 76969, 76970, 76976, 76981, 76991, 76998, 80316, 80333, 82557, 82560, 82568, 82569, 82614, 82632, 82647, 82648, 82654, 82681, 82686, 82705, 82718, 82724, 82725, 82806, 82808, 82828, 82832, 82833, 82833, 82835, 82919, 82919, 82938, 82941, 82944, 83008, 83009, 83010, 83011, 83012, 83029, 83043, 83072, 83331, 83332, 83338, 83341, 83390, 83391, 83603, 83604, 83619, 83652, 83653, 83800, 83801, 83866, 83900, 83908, 83942, 83948, 83960, 83998, 84419, 84439, 84440, 84453, 84454, 84455, 84457, 84458, 84488, 84497, 84701, 84705, 84723, 84731, 84817, 84818, 84846, 84847, 84848, 84849, 84862, 84863, 84891, 84929, 84932, 84937, 84943, 84972, 85009, 85036, 85053, 85063, 85066, 85069, 85103, 85115, 85118, 85151, 85152, 85162, 85181, 85439, 85461, 85463, 85465, 85466, 85468, 85495, 85627, 85628, 85696, 85697, 85698, 85699, 85860, 86014, 86072, 86073, 86075, 86117, 86119, 86120, 86123, 86210, 86211, 86212, 86219, 86220, 86222, 86225, 86227, 86230, 86266, 86267, 86268, 86270, 86279, 86300, 86301, 86302, 86304, 86306, 86307, 86308, 86310, 86311, 86314, 86325, 86336, 86337, 86338, 86357, 86382, 86383, 86385, 86388, 86402, 86451, 86455, 86472, 86493, 86493, 86507, 86550, 86602, 86605, 86614, 86621, 86622, 86625, 86902, 86904, 86919, 86920, 86921, 86943, 86951, 86963, 86973, 86974, 87003, 87014, 87027, 87028, 87032, 87039, 87048, 87049, 87057, 87071, 87082, 87141, 87144, 87301, 87303, 87321, 87338, 87602, 87606, 87608, 100039, 100094, 100203, 100244, 100245, 100428, 100433, 100437, 100439, 100441, 100454, 100455, 100490, 100544, 100547, 100569, 100571, 100572, 100573, 100584, 100591, 100602, 100616, 100617, 100619, 100642, 100659, 100678, 100772, 100773, 100782, 100807, 100824, 100827, 100868, 100885, 100891, 101081, 101213, 101218, 101308, 101405, 102496, 104373, 250090, 250100, 250439, 250677, 250678, 557777, 557784, 557786, 557787, 557803, 557833, 557876, 557880, 557885, 557938, 557943, 557990, 558001, 558008, 558014, 558040, 558052, 558060, 558154, 558155, 558156, 558157, 558160, 558163, 558181, 558186, 558207, 558208, 558210, 558284, 558289, 558290, 558291, 558292, 558294, 558295, 558304, 558311, 558312, 558361, X1727, 6983, 10000, 10002, 10006, 10178, 10392, 10393, 10410, 10418, 10435, 10493, 13173, 13178, 13178, 13245, 13257, 13283, 13284, 13293, 13970, 14070, 14169, 14177, 26294, 38195, 38196, 38207, 38268, 38314, 38342, 38361, 38423, 38608, 38610, 38625, 38626, 38634, 38656, 38679, 38689, 38693, 38695, 38712, 38743, 38745, 38963, 40936, 41120, 41121, 41420, 41463, 41468, 50230, 50322, 50427, 50446, 50447, 52450, 59652, 62868, 62950, 62997, 76391, 76578, 76829, 76837, 76925, 76940, 76957, 76958, 76959, 76960, 76967, 76973, 80318, 80339, 82503, 82515, 82516, 82561, 82571, 82613, 82630, 82646, 82656, 82674, 82675, 82712, 82720, 82722, 82726, 82728, 82805, 82809, 82831, 82834, 82920, 82942, 82949, 82954, 83001, 83007, 83031, 83074, 83083, 83308, 83319, 83369, 83370, 83648, 83651, 83698, 83909, 83936, 83943, 83944, 83947, 84420, 84434, 84461, 84703, 84851, 84857, 84858, 84893, 84931, 84938, 84939, 84963, 84964, 85029, 85030, 85037, 85109, 85117, 85147, 85148, 85149, 85166, 85167, 85168, 85184, 85402, 85403, 85405, 85437, 85438, 85462, 85467, 85484, 85486, 85492, 85493, 85494, 85683, 86015, 86070, 86071, 86078, 86213, 86216, 86221, 86221, 86226, 86228, 86232, 86309, 86344, 86358, 86359, 86384, 86386, 86389, 86394, 86395, 86397, 86400, 86543, 86579, 86601, 86606, 86607, 86611, 86613, 86618, 86619, 86623, 86901, 86938, 86939, 86942, 86964, 86976, 86979, 86980, 86990, 87005, 87016, 87017, 87031, 87045, 87050, 87051, 87079, 87136, 87137, 87138, 87142, 87169, 87175, 87178, 87196, 87320, 87333, 87363, 87609, 100426, 100438, 100443, 100457, 100481, 100489, 100494, 100549, 100555, 100556, 100557, 100604, 100605, 100614, 100615, 100618, 100770, 100780, 100825, 100834, 100835, 100848, 100855, 100867, 101076, 101079, 101080, 101132, 101240, 101563, 102081, 102335, 102337, 102338, 102339, 102340, 102341, 102342, 102344, 102376, 102385, 102388, 102609, 250043, 250092, 250313, 250679, 505640, 557789, 557792, 557794, 557812, 557883, 557935, 557940, 557988, 557991, 558009, 558010, 558013, 558017, 558018, 558019, 558024, 558025, 558026, 558030, 558063, 558064, 558158, 558174, 558184, 558190, 558195, 558205, 558224, 558226, 558285, 558293, 558302, 558308, 558310, 558366, 558370, 20278751, 82730, 83073, 10405, 13253, 38975, 76831, 82617, 82657, 83956, 84712, 86223, 86451, 100322, 100633, 100633, and 104199
Root Cause
Device Design
Action Taken
On 2/7/08, the firm issued an URGENT-DEVICE CORRECTION letter via certified mail to their customers. The letter explains the issue and states that the firm will upgrade the collimator by installing a safety plate to prevent the collimator form dislodging from the stand should the screws become lose. The letter also states, "To avoid the potential risk of the collimator falling from the stand, please test the collimator for being loose. Rock the collimator forwards and backwards by grabbing the sides and gently shaking the unit. Please contact Philips immediately if the collimator is loose and do not use the system until Philips can service the unit." The service representatives will visit the sites and install a safety plate to prevent the collimator from falling should the securing screws become loose. Contact Sarah Baxter at 425-487-7665 or Philips Call Center at 800-722-9377, #5, #2 if you have questions.