Z-1886-2008

Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The...

Name: Z-1886-2008 Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-02-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-02-07 / Terminated / root cause: design

FDA source

Philips Medical Systems North America Co. Phillips began a recall of 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... on 2008-02-07. The reason FDA records is "The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1886-2008
Status: Terminated
Initiated: 2008-02-07
Posted: 2008-09-16
Terminated: 2011-03-08
Recalling firm: Philips North America LLC
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.
Product code: IZW Collimator, Automatic, Radiographic
Reason for recall: The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.
Root cause tag: design
FDA 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 in commerce: 709 devices
Distribution: Units were distributed nationwide to medical centers and hospitals, including military and VA hospitals.
Product codes and lots: 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

Product code IZW

K951372Class IIPhilips Gallileo Automatic Collimator (or Beam Limiting Device)Philips Medical Systems, Inc. / cleared 1995-05-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)