Class 2 Device Recall DigitalDiagnost

• Date Initiated by Firm: September 21, 2023
• Date Posted: November 08, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0274-2024
• Recall Event ID: 93200
• 510(K)Number: K210692
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
• Code Information: 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, 10001075, 10001091, 10001107, 10001092, 10001108, 10001096, 10001109, 10001099, 10001100, 10001098, SN20000044, 10001111, 10001126, 20010235, 10001115, 10001137, 10001121, 10001117, 10001123, 10001127, 10001119, 10001138, 10001120, 10001129, 10001143, 10001131, 10001134, SN15000180, 10001130, SN17000398, SN15000152, SN19000297, SN20000120, SN18861018, SN18861015, SN18861019, SN18861022, SN19861039.
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Care Solution Center; 1-800-722-9377
• Manufacturer Reason for Recall: Potential for units suspended on the ceiling to fail and fall.
• FDA Determined Cause: 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.
• Quantity in Commerce: 366 units
• Distribution: Nationwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAA and Original Applicant = Philips Medical Systems DMC GmbH