{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "64514", "product_res_number": "Z-0908-2007", "event_date_initiated": "2007-07-23", "event_date_posted": "2007-09-25", "recall_status": "Terminated", "event_date_terminated": "2012-09-17", "res_event_number": "44910", "product_code": "MQB", "k_numbers": [ "K982795" ], "product_description": "Philips Digital Diagnost X-Ray system", "code_info": "Site numbers 103982, 104073, 105158, 105629, 504343, 505773.  Added sites: 104303, 38280, 44807, 59667, 76907, 76909, 76974, 82641, 82652, 82657, 82724, 83072, 83073, 84712, 84862, 84863, 86072, 86987, 86988, 102030, 102100, 102489, 102713, 102717, 102719, 102787, 102905, 102911, 103109, 103165, 103274, 103437, 103438, 103439, 103453, 103893, 103894, 103941, 104465, 104902, 104903, 104904, 104937, 104938, 105415, 105621, 105623, 105625, 105668, 250094, 250470, 250471, 250875, 500002, 504546, 504989, 505038, 505347, 505350, 505351, 505352, 505605, 505684, 505944, 506184, 506343, 506643, 506645, 506826, 506839, 506848, 519148, 519149, 519150, 519568, 519739, 519904, 520297, 520298, 520299, 520385, 520687, 520698, 520766, 520808, 520811, 520828, 520836, 520978, 520984, 520986, 521004, 521089, 521110, 521412, 521539, 521660, 521668, 521893, 521894, 521995, 521997, 522213, 522215, 522244, 522281, 522360, 522361, 522362, 522364, 522367, 522398, 522475, 530411, 530412, 530415, 530455, 530516, 530611, 530696, 530716, 530779, 530787, 530789, 530791, 530792, 530796, 530800, 530806, 531773, 531825, 531833, 531858, 531975, 531994, 531995, 532138, 532141, 532167, 532168, 532169, 532171, 532206, 532211, 532278, 532364, 532421, 532422, 532815, 532816, 532817, 532818, 533244, 533317, 533319, 533338, 533426, 533468, 533534, 533571, 533769, 533915, 533916, 533920, 533949, 533950, 534082, 534279, 534435, 534539, 534570, 534622, 534718, 534800, 534801, 534836, 534866, 535146, 535334, 535381, 535383, 535549, 535626, 535773, 535774, 535786, 535933, 536002, 536039, 536043, 536062, 536064, 536128, 536129, 536441, 536448, 536614, 536913, 536939, 537163, 537184, 537455, 537753, 537755, 537762, 537840, 537918, 537948, 537950, 537974, 538139, 538154, 538166, 538304, 538437, 538478, 539680, 540173, 540199, 540474, 540477, 542194, 543376, 545097, 549011, 549725, and 557777.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems North America Co. Phillips", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Sarah Baxter\n425-487-7665", "reason_for_recall": "Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.", "root_cause_description": "Other", "action": "On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.", "product_quantity": "6 units + 227 units added = 233", "distribution_pattern": "Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.", "openfda": { "k_number": [ "K202722", "K210619", "K222661", "K042023", "K103348", "K232753", "K213529", "K020635", "K133139", "K214030", "K133120", "K102619", "K242770", "K250665", "K050987", "K111312", "K131408", "K062390", "K013897", "K112527", "K203703", "K211790", "K141736", "K012750", "K120020", "K123345", "K231959", "K102479", "K141602", "K053634", "K181003", "K060433", "K140235", "K162519", "K123740", "K210985", "K161459", "K122182", "K100001", "K163703", "K142475", "K152138", "K121948", "K122736", "K141765", "K172784", "K221549", "K200418", "K200622", "K200668", "K023586", "K181631", "K080064", "K220559", "K171716", "K122173", "K172681", "K171175", "K141743", "K092669", "K112309", "K133442", "K221394", "K212051", "K102327", "K123644", "K051998", "K241346", "K201043", "K183713", "K201528", "K210919", "K031447", "K190368", "K063039", "K081624", "K050925", "K162504", "K181565", "K042386", "K082450", "K221461", "K081648", "K132921", 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