Philips Medical Systems North America Co. Phillips: 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.

Recall number

Z-1886-2008

Recalling firm

Philips Medical Systems North America Co. Phillips

Product

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.

Status

Terminated

Initiated

2008-02-07

Posted

2008-09-16

Terminated

2011-03-08

Reason

The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.

Root cause

Device Design

Action

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.

Quantity

709 devices

Distribution

Units were distributed nationwide to medical centers and hospitals, including military and VA hospitals.

Lot, serial or model codes

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

510(k) numbers

["K951372"]

PMA numbers

not on file

Product code

IZW

Firm FEI

1000524572

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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