{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "203640",
      "product_res_number": "Z-0274-2024",
      "event_date_initiated": "2023-09-21",
      "event_date_posted": "2023-11-08",
      "recall_status": "Open, Classified",
      "res_event_number": "93200",
      "product_code": "JAA",
      "k_numbers": [
        "K210692"
      ],
      "product_description": "DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.",
      "code_info": "Model No. 712027, 712031 & 712226; UDI: (01)00884838065321(21) SN18000276 , (01)00884838065321(21) SN18000158 , (01)00884838065321(21) SN19000178 , (01)00884838065321(21) SN18000227 , (01)00884838065321(21) SN18000256 , (01)00884838065321(21) SN18000228 , (01)00884838065321(21) SN18000257 , (01)00884838065321(21) SN18000247 , (01)00884838065321(21) SN18000252 , (01)00884838065321(21) SN18000238 , (01)00884838065321(21) SN19000195 , (01)00884838065321(21) SN19000101 , (01)00884838065321(21) SN19000180 , (01)00884838065321(21) SN18000283 , (01)00884838065321(21) SN18000299 , (01)00884838065321(21) SN19000337 , (01)00884838065321(21) SN18000305 , (01)00884838065321(21) SN19000019 , (01)00884838065321(21) SN18000224 , (01)00884838065321(21) SN18000248 , (01)00884838065321(21) SN18000223 , (01)00884838065321(21) SN18000394 , (01)00884838065321(21) SN18000286 , (01)00884838065321(21) SN19000247 , (01)00884838065321(21) SN18000232 , (01)00884838065321(21) SN19000292 , (01)00884838065321(21) SN18000282 , (01)00884838065321(21) SN18000296 , (01)00884838065321(21) SN20000083 , (01)00884838065321(21) SN18000266 , (01)00884838065321(21) SN18000335 , (01)00884838065321(21) SN18000441 , (01)00884838065321(21) SN19000147 , (01)00884838065321(21) SN18000298 , (01)00884838065321(21) SN18000295 , (01)00884838065321(21) SN18000427 , (01)00884838065321(21) SN18000450 , (01)00884838065321(21) SN19000300 , (01)00884838065321(21) SN19000034 , (01)00884838065321(21) SN18000271 , (01)00884838065321(21) SN19000080 , (01)00884838065321(21) SN19000060 , (01)00884838065321(21) SN18000440 , (01)00884838065321(21) SN19000136 , (01)00884838065321(21) SN18000395 , (01)00884838065321(21) SN19000115 , (01)00884838065321(21) SN19000212 , (01)00884838065321(21) SN19000102 , (01)00884838065321(21) SN18000300 , (01)00884838065321(21) SN18000398 , (01)00884838065321(21) SN19000028 , (01)00884838065321(21) SN19000135 , (01)00884838065321(21) 20000001 , (01)00884838065321(21) SN18000413 , (01)00884838065321(21) SN19000256 , (01)00884838065321(21) SN19000336 , (01)00884838065321(21) SN19000172 , (01)00884838065321(21) SN18000447 , (01)00884838065321(21) 10001078 , (01)00884838065321(21) SN19000155 , (01)00884838065321(21) SN19000259 , (01)00884838065321(21) SN19000349 , (01)00884838065321(21) SN18000407 , (01)00884838065321(21) SN19000350 , (01)00884838065321(21) SN19000050 , (01)00884838065321(21) SN19000291 , (01)00884838065321(21) SN19000142 , (01)00884838065321(21) SN18000420 , (01)00884838065321(21) SN19000128 , (01)00884838065321(21) SN19000120 , (01)00884838065321(21) SN19000006 , (01)00884838065321(21) SN19000090 , (01)00884838065321(21) SN19000123 , (01)00884838065321(21) SN19000368 , (01)00884838065321(21) SN19000171 , (01)00884838065321(21) SN19000048 , (01)00884838065321(21) SN19000277 , (01)00884838065321(21) SN19000100 , (01)00884838065321(21) SN19000179 , (01)00884838065321(21) SN19000190 , (01)00884838065321(21) SN19000332 , (01)00884838065321(21) SN19000334 , (01)00884838065321(21) SN19000032 , (01)00884838065321(21) SN19000279 , (01)00884838065321(21) SN19000293 , (01)00884838065321(21) SN19000063 , (01)00884838065321(21) SN19000288 , (01)00884838065321(21) SN19000089 , (01)00884838065321(21) SN19000196 , (01)00884838065321(21) SN19000220 , (01)00884838065321(21) SN19000164 , (01)00884838065321(21) SN19000181 , (01)00884838065321(21) SN19000157 , (01)00884838065321(21) SN19000199 , (01)00884838065321(21) SN19000221 , (01)00884838065321(21) SN19000342 , (01)00884838065321(21) SN19000339 , (01)00884838065321(21) 19000253 , (01)00884838065321(21) SN19000273 , (01)00884838065321(21) SN20000046 , (01)00884838065321(21) SN19000152 , (01)00884838065321(21) SN19000290 , (01)00884838065321(21) SN20000016 , (01)00884838065321(21) SN19000362 , (01)00884838065321(21) SN19000193 , (01)00884838065321(21) SN20000043 , (01)00884838065321(21) SN19000352 , (01)00884838065321(21) SN19000270 , (01)00884838065321(21) SN19000266 , (01)00884838065321(21) SN19000284 , (01)00884838065321(21) SN19000363 , (01)00884838065321(21) SN20000241 , (01)00884838065321(21) SN20000161 , (01)00884838065321(21) SN20000085 , (01)00884838065321(21) SN19000320 , (01)00884838065321(21) SN20000286 , (01)00884838065321(21) SN20000168 , (01)00884838065321(21) SN20000010 , (01)00884838065321(21) SN20000116 , (01)00884838065321(21) SN19000304 , (01)00884838065321(21) SN20000042 , (01)00884838065321(21) SN20000057 , (01)00884838065321(21) SN15000371 , (01)00884838065321(21) SN18000340 , (01)00884838065321(21) SN15000189 , (01)00884838065321(21) SN18000268 , (01)00884838065321(21) SN18000044 , (01)00884838065321(21) SN18000221 , (01)00884838065321(21) SN15000323 , (01)00884838065321(21) SN15000186 , (01)00884838065321(21) SN15000264 , (01)00884838065321(21) SN15000372 , (01)00884838065321(21) SN16000147 , (01)00884838065321(21) SN16000146 , (01)00884838065321(21) SN16000037 , (01)00884838065321(21) SN16000043 , (01)00884838065321(21) SN16000202 , (01)00884838065321(21) SN16000263 , (01)00884838065321(21) SN17000055 , (01)00884838065321(21) SN16000141 , (01)00884838065321(21) SN16000095 , (01)00884838065321(21) SN16000125 , (01)00884838065321(21) SN16000121 , (01)00884838065321(21) SN16000203 , (01)00884838065321(21) SN16000218 , (01)00884838065321(21) SN16000144 , (01)00884838065321(21) SN16000151 , (01)00884838065321(21) SN16000211 , (01)00884838065321(21) SN16000235 , (01)00884838065321(21) SN16000329 , (01)00884838065321(21) SN17000288 , (01)00884838065321(21) SN16000225 , (01)00884838065321(21) SN17000106 , (01)00884838065321(21) SN16000328 , (01)00884838065321(21) SN17000009 , (01)00884838065321(21) SN18000316 , (01)00884838065321(21) SN20000126 , (01)00884838065321(21) SN16000352 , (01)00884838065321(21) SN17000333 , (01)00884838065321(21) SN16000436 , (01)00884838065321(21) SN16000266 , (01)00884838065321(21) SN17000005 , (01)00884838065321(21) SN16000398 , (01)00884838065321(21) SN17000156 , (01)00884838065321(21) SN16000394 , (01)00884838065321(21) SN16000387 , (01)00884838065321(21) SN16000401 , (01)00884838065321(21) SN16000386 , (01)00884838065321(21) SN16000371 , (01)00884838065321(21) SN16000373 , (01)00884838065321(21) SN16000390 , (01)00884838065321(21) SN17000039 , (01)00884838065321(21) SN16000478 , (01)00884838065321(21) SN18000315 , (01)00884838065321(21) SN20000119 , (01)00884838065321(21) SN17000127 , (01)00884838065321(21) SN18000056 , (01)00884838065321(21) SN17000086 , (01)00884838065321(21) SN17000129 , (01)00884838065321(21) SN17000143 , (01)00884838065321(21) SN17000158 , (01)00884838065321(21) SN17000157 , (01)00884838065321(21) SN16000435 , (01)00884838065321(21) SN17000263 , (01)00884838065321(21) SN16000430 , (01)00884838065321(21) SN19000289 , (01)00884838065321(21) SN19000333 , (01)00884838065321(21) SN17000362 , (01)00884838065321(21) SN17000303 , (01)00884838065321(21) SN17000097 , (01)00884838065321(21) SN17000155 , (01)00884838065321(21) SN18000028 , (01)00884838065321(21) SN17000100 , (01)00884838065321(21) SN17000217 , (01)00884838065321(21) SN17000082 , (01)00884838065321(21) SN17000084 , (01)00884838065321(21) SN17000160 , (01)00884838065321(21) SN17000359 , (01)00884838065321(21) SN17000216 , (01)00884838065321(21) SN17000166 , (01)00884838065321(21) SN17000151 , (01)00884838065321(21) SN17000185 , (01)00884838065321(21) SN17000370 , (01)00884838065321(21) SN17000235 , (01)00884838065321(21) SN17000130 , (01)00884838065321(21) SN18000001 , (01)00884838065321(21) SN17000184 , (01)00884838065321(21) SN17000349 , (01)00884838065321(21) SN18000214 , (01)00884838065321(21) SN17000252 , (01)00884838065321(21) SN17000264 , (01)00884838065321(21) SN17000179 , (01)00884838065321(21) SN17000329 , (01)00884838065321(21) SN17000233 , (01)00884838065321(21) SN17000305 , (01)00884838065321(21) SN17000328 , (01)00884838065321(21) SN17000231 , (01)00884838065321(21) SN17000234 , (01)00884838065321(21) SN18000123 , (01)00884838065321(21) SN18000165 , (01)00884838065321(21) SN17000261 , (01)00884838065321(21) SN17000444 , (01)00884838065321(21) SN17000299 , (01)00884838065321(21) SN17000246 , (01)00884838065321(21) SN17000352 , (01)00884838065321(21) SN17000335 , (01)00884838065321(21) SN18000045 , (01)00884838065321(21) SN17000411 , (01)00884838065321(21) SN18000080 , (01)00884838065321(21) SN18000032 , (01)00884838065321(21) SN17000399 , (01)00884838065321(21) SN18000121 , (01)00884838065321(21) SN18000145 , (01)00884838065321(21) SN20000090 , (01)00884838065321(21) SN18000290 , (01)00884838065321(21) SN17000376 , (01)00884838065321(21) SN17000414 , (01)00884838065321(21) SN18000061 , (01)00884838065321(21) SN20000136 , (01)00884838065321(21) 19000252 , (01)00884838065321(21) SN10001026 , (01)00884838065321(21) SN18000153 , (01)00884838065321(21) SN17000422 , (01)00884838065321(21) SN18000374 , (01)00884838065321(21) 10001073 , (01)00884838065321(21) SN18000027 , (01)00884838065321(21) SN18000323 , (01)00884838065321(21) SN18000131 , (01)00884838065321(21) SN18000151 , (01)00884838065321(21) SN19000093 , (01)00884838065321(21) SN18000236 , (01)00884838065321(21) SN18000097 , (01)00884838065321(21) SN18000250 , (01)00884838065321(21) SN18000219 , (01)00884838065321(21) SN18000063 , (01)00884838065321(21) SN18000122 , (01)00884838065321(21) SN19000127 , (01)00884838065321(21) SN18000172 , (01)00884838065321(21) SN19000201 , (01)00884838065321(21) SN18000118 , (01)00884838065321(21) SN18000251 , (01)00884838065321(21) SN18000160 , (01)00884838065321(21) SN18000234 , (01)00884838065321(21) SN18000119 , (01)00884838065321(21) 18000319 , (01)00884838065321(21) SN18000147 , (01)00884838065321(21) SN18000263 , (01)00884838065321(21) SN18000267 , (01)00884838065321(21) SN20000147 , (01)00884838065321(21) SN18000156 , (01)00884838065321(21) SN18000150 , (01)00884838065321(21) SN18000148 , (01)00884838065321(21) SN18000275 , (01)00884838065321(21) SN18000185 , (01)00884838065321(21) SN20000068 , (01)00884838065321(21) SN20000021 , (01)00884838065321(21) SN19000367 , (01)00884838065321(21) SN20000123 , (01)00884838065321(21) SN20000178 , (01)00884838065321(21) SN19000356 , (01)00884838065321(21) SN20000208 , (01)00884838065321(21) 10001090 , (01)00884838065321(21) SN20000172 , (01)00884838065321(21) SN20000145 , (01)00884838065321(21) SN20000272 , (01)00884838065321(21) SN20000171 , (01)00884838065321(21) SN20000179 , (01)00884838065321(21) SN20000177 , (01)00884838065321(21) SN20000170 , (01)00884838065321(21) SN20000297 , (01)00884838065321(21) SN20000298 , (01)00884838065321(21) SN20000301 , (01)00884838065321(21) SN20000271 , (01)00884838065321(21) SN20000211 , (01)00884838065321(21) SN20000268 , (01)00884838065321(21) SN20000409 , (01)00884838065321(21) SN10001035 , (01)00884838065321(21) SN10001007 , (01)00884838065321(21) SN20000267 , (01)00884838065321(21) 10001076 , (01)00884838065321(21) SN20000348 , (01)00884838065321(21) SN10001018 , (01)00884838065321(21) SN10001009 , (01)00884838065321(21) SN20000347 , (01)00884838065321(21) SN10001008 , (01)00884838065321(21) SN20000323 , (01)00884838065321(21) SN20000339 , (01)00884838065321(21) 10001065 , (01)00884838065321(21) SN20000373 , (01)00884838065321(21) SN10001006 , (01)00884838065321(21) 10001072 , (01)00884838065321(21) 10001103 , (01)00884838065321(21) SN20000401 , (01)00884838065321(21) SN10001034 , (01)00884838065321(21) SN10001036 , (01)00884838065321(21) SN10001012 , (01)00884838065321(21) SN10001039 , (01)00884838065321(21) SN10001022 , (01)00884838065321(21) 10001087 , (01)00884838065321(21) SN10001056 , (01)00884838065321(21) 10001070 , (01)00884838065321(21) 10001086 , (01)00884838065321(21) 10001075 , (01)00884838065321(21) 10001091 , (01)00884838065321(21) 10001107 , (01)00884838065321(21) 10001092 , (01)00884838065321(21) 10001108 , (01)00884838065321(21) 10001096 , (01)00884838065321(21) 10001109 , (01)00884838065321(21) 10001099 , (01)00884838065321(21) 10001100 , (01)00884838065321(21) 10001098 , (01)00884838065321(21) SN20000044 , (01)00884838065321(21) 10001111 , (01)00884838065321(21) 10001126 , (01)00884838065321(21) 20010235 , (01)00884838065321(21) 10001115 , (01)00884838065321(21) 10001137 , (01)00884838065321(21) 10001121 , (01)00884838065321(21) 10001117 , (01)00884838065321(21) 10001123 , (01)00884838065321(21) 10001127 , (01)00884838065321(21) 10001119 , (01)00884838065321(21) 10001138 , (01)00884838065321(21) 10001120 , (01)00884838065321(21) 10001129 , (01)00884838065321(21) 10001143 , (01)00884838065321(21) 10001131 , (01)00884838065321(21) 10001134 , (01)00884838065321(21) SN15000180 , (01)00884838065321(21) 10001130 , (01)00884838065321(21) SN17000398 , (01)00884838065321(21) SN15000152 , (01)00884838065321(21) SN19000297 , (01)00884838065321(21) SN20000120 , (01)00884838087354(21)SN18861018, (01)00884838087354(21)SN18861019, (01)00884838087354(21)SN18861022, (01)00884838085671(21)SN19861039, (01)00884838085671(21)SN19861039; Serial No. SN15000410, SN15000417, SN15000435, SN15000265, SN15000185, SN15000110, SN18000276, SN18000158, SN19000178, SN18000227, SN18000256, SN18000228, SN18000257, SN18000247, SN18000252, SN18000238, SN19000195, SN19000101, SN19000180, SN18000283, SN18000299, SN19000337, SN18000305, SN19000019, SN18000224, SN18000248, SN18000223, SN18000394, SN18000286, SN19000247, SN18000232, SN19000292, SN18000282, SN18000296, SN20000083, SN18000266, SN18000335, SN18000441, SN19000147, SN18000298, SN18000295, SN18000427, SN18000450, SN19000300, SN19000034, SN18000271, SN19000080, SN19000060, SN18000440, SN19000136, SN18000395, SN19000115, SN19000212, SN19000102, SN18000300, SN18000398, SN19000028, SN19000135, 20000001, SN18000413, SN19000256, SN19000336, SN19000172, SN18000447, 10001078, SN19000155, SN19000259, SN19000349, SN18000407, SN19000350, SN19000050, SN19000291, SN19000142, SN18000420, SN19000128, SN19000120, SN19000006, SN19000090, SN19000123, SN19000368, SN19000171, SN19000048, SN19000277, SN19000100, SN19000179, SN19000190, SN19000332, SN19000334, SN19000032, SN19000279, SN19000293, SN19000063, SN19000288, SN19000089, SN19000196, SN19000220, SN19000164, SN19000181, SN19000157, SN19000199, SN19000221, SN19000342, SN19000339, 19000253, SN19000273, SN20000046, SN19000152, SN19000290, SN20000016, SN19000362, SN19000193, SN20000043, SN19000352, SN19000270, SN19000266, SN19000284, SN19000363, SN20000241, SN20000161, SN20000085, SN19000320, SN20000286, SN20000168, SN20000010, SN20000116, SN19000304, SN20000042, SN20000057, SN15000371, SN18000340, SN15000189, SN18000268, SN18000044, SN18000221, SN15000323, SN15000186, SN15000264, SN15000372, SN16000147, SN16000146, SN16000037, SN16000043, SN16000202, SN16000263, SN17000055, SN16000141, SN16000095, SN16000125, SN16000121, SN16000203, SN16000218, SN16000144, SN16000151, SN16000211, SN16000235, SN16000329, SN17000288, SN16000225, SN17000106, SN16000328, SN17000009, SN18000316, SN20000126, SN16000352, SN17000333, SN16000436, SN16000266, SN17000005, SN16000398, SN17000156, SN16000394, SN16000387, SN16000401, SN16000386, SN16000371, SN16000373, SN16000390, SN17000039, SN16000478, SN18000315, SN20000119, SN17000127, SN18000056, SN17000086, SN17000129, SN17000143, SN17000158, SN17000157, SN16000435, SN17000263, SN16000430, SN19000289, SN19000333, SN17000362, SN17000303, SN17000097, SN17000155, SN18000028, SN17000100, SN17000217, SN17000082, SN17000084, SN17000160, SN17000359, SN17000216, SN17000166, SN17000151, SN17000185, SN17000370, SN17000235, SN17000130, SN18000001, SN17000184, SN17000349, SN18000214, SN17000252, SN17000264, SN17000179, SN17000329, SN17000233, SN17000305, SN17000328, SN17000231, SN17000234, SN18000123, SN18000165, SN17000261, SN17000444, SN17000299, SN17000246, SN17000352, SN17000335, SN18000045, SN17000411, SN18000080, SN18000032, SN17000399, SN18000121, SN18000145, SN20000090, SN18000290, SN17000376, SN17000414, SN18000061, SN20000136, 19000252, SN10001026, SN18000153, SN17000422, SN18000374, 10001073, SN18000027, SN18000323, SN18000131, SN18000151, SN19000093, SN18000236, SN18000097, SN18000250, SN18000219, SN18000063, SN18000122, SN19000127, SN18000172, SN19000201, SN18000118, SN18000251, SN18000160, SN18000234, SN18000119, 18000319, SN18000147, SN18000263, SN18000267, SN20000147, SN18000156, SN18000150, SN18000148, SN18000275, SN18000185, SN20000068, SN20000021, SN19000367, SN20000123, SN20000178, SN19000356, SN20000208, 10001090, SN20000172, SN20000145, SN20000272, SN20000171, SN20000179, SN20000177, SN20000170, SN20000297, SN20000298, SN20000301, SN20000271, SN20000211, SN20000268, SN20000409, SN10001035, SN10001007, SN20000267, 10001076, SN20000348, SN10001018, SN10001009, SN20000347, SN10001008, SN20000323, SN20000339, 10001065, SN20000373, SN10001006, 10001072, 10001103, SN20000401, SN10001034, SN10001036, SN10001012, SN10001039, SN10001022, 10001087, SN10001056, 10001070, 10001086, 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      "firm_fei_number": "3016618143",
      "recalling_firm": "Philips North America Llc",
      "address_1": "222 Jacobs St",
      "city": "Cambridge",
      "state": "MA",
      "postal_code": "02141-2289",
      "additional_info_contact": "Philips Customer Care Solution Center\n1-800-722-9377",
      "reason_for_recall": "Potential for units suspended on the ceiling to fail and fall.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm distributed recall notifications dated 8/31/2023 via FedEx to affected consignees. Consignees are instructed to immediately stop use of affected devices and contact their local Philips service representative if the Ceiling Suspension becomes unstable, if moving the Ceiling Suspended X-Ray Tube requires a high amount of force, or if moving the Ceiling Suspended X-Ray Tube is noticeably hampered. The recall notice is to be circulated among all device users, so they are aware of this issue and placed as an addendum in the IFU. Consignees are to complete the provided response form and return it to Philips no later than 30 days from notification receipt via email to pd.cnr@philips.com. Philips will contact consignees to schedule a time for a Field Service Engineer to visit customer sites to inspect affected systems and correct the issue. Consignees with any questions are to contact the Customer Care Solutions Center at 1-800-722-9377.",
      "product_quantity": "366 units",
      "distribution_pattern": "Nationwide distribution.",
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}