Class 2 Device Recall Philips Gallileo Automatic Collimator

• Date Initiated by Firm: February 07, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on March 08, 2011
• Recall Number: Z-1886-2008
• Recall Event ID: 46216
• 510(K)Number: K951372
• Product Classification: Automatic Radiographic Collimator or Beam Limiting Device - Product Code IZW
• 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.
• Code Information: 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, 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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
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Sarah Baxter; 425-487-7665
• Manufacturer Reason for Recall: The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZW and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.