medical Class II Updated 2023-11-15

Philips North America Llc recalls ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system

Recalled Product

ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system


Hazard / Issue

Potential for units suspended on the ceiling to fail and fall.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. 706100 & 706110; UDI: (01)00884838085619(21) SN18000019 , (01)00884838085619(21) SN18000019 , (01)00884838085619(21) SN18000002 , (01)00884838085619(21) 721815121706 , (01)00884838085619(21) 10000015 , (01)00884838085619(21) SN18000014 , (01)00884838085619(21) 20000070 , (01)00884838085619(21) SN19000007 , (01)00884838085619(21) 10000035 , (01)00884838085619(21) 10000011 , (01)00884838085619(21) SN18000021 , (01)00884838085619(21) SN19000002 , (01)00884838085619(21) SN19000001 , (01)00884838085619(21) 10000021 , (01)00884838085619(21) 20000054 , (01)00884838085619(21) SN19000006 , (01)00884838085619(21) SN19000011 , (01)00884838085619(21) SN19000012 , (01)00884838085619(21) SN19000005 , (01)00884838085619(21) 10000051 , (01)00884838085619(21) 20000078 , (01)00884838085619(21) 10000050 , (01)00884838085619(21) 20000045 , (01)00884838085619(21) 10000008 , (01)00884838085619(21) SN19000018 , (01)00884838085619(21) 10000017 , (01)00884838085619(21) 10000045 , (01)00884838085619(21) SN19000017 , (01)00884838085619(21) SN19000014 , (01)00884838085619(21) 10000013 , (01)00884838085619(21) 10000010 , (01)00884838085619(21) 10000031 , (01)00884838085619(21) 10000030 , (01)00884838085619(21) 10000018 , (01)00884838085619(21) 10000024 , (01)00884838085619(21) 10000020 , (01)00884838085619(21) 10000025 , (01)00884838085619(21) 10000026 , (01)00884838085619(21) 10000028 , (01)00884838085619(21) SN10001008 , (01)00884838085619(21) 10000036 , (01)00884838085619(21) 10000037 , (01)00884838085619(21) 10000043 , (01)00884838085619(21) 20000026 , (01)00884838085619(21) SN10001004 , (01)00884838085619(21) 10000052 , (01)00884838085619(21) 20000051 , (01)00884838085619(21) 10001028 , (01)00884838085619(21) 10000040 , (01)00884838085619(21) 20000086 , (01)00884838085619(21) 20000052 , (01)00884838085619(21) 20000079 , (01)00884838085619(21) 20000068 , (01)00884838085619(21) 10001022 , (01)00884838085619(21) 20000089 , (01)00884838085619(21) 10001036 , (01)00884838085619(21) SN10001007 , (01)00884838085619(21) 10000023 , (01)00884838085619(21) SN10001002 , (01)00884838085619(21) 10001040 , (01)00884838085619(21) 10001046 , (01)00884838085619(21) 10001023 , (01)00884838085619(21) 10001027 , (01)00884838085619(21) 10001109 , (01)00884838085619(21) 10001026 , (01)00884838085619(21) 10001042 , (01)00884838085619(21) 10001044 , (01)00884838085619(21) 10001051 , (01)00884838085619(21) 20000063 , (01)00884838085619(21) 721815121708 , (01)00884838103221(21) 10001158 , (01)00884838103221(21) 10001158 , (01)00884838103221(21) 10001052 , (01)00884838103221(21) 10001098 , (01)00884838103221(21) 10001061 , (01)00884838103221(21) 10001074 , (01)00884838103221(21) 10001102 , (01)00884838103221(21) 10001060 , (01)00884838103221(21) 10001065 , (01)00884838103221(21) 10001059 , (01)00884838103221(21) 10001067 , (01)00884838103221(21) 10001073 , (01)00884838103221(21) 10001072 , (01)00884838103221(21) 10001089 , (01)00884838103221(21) 10001078 , (01)00884838103221(21) 10001075 , (01)00884838103221(21) 10001105 , (01)00884838103221(21) 10001093 , (01)00884838103221(21) 10001085 , (01)00884838103221(21) 10001101 , (01)00884838103221(21) 10001086 , (01)00884838103221(21) 10001100 , (01)00884838103221(21) 10001091 , (01)00884838103221(21) 10001121 , (01)00884838103221(21) 10001077 , (01)00884838103221(21) 10001096 , (01)00884838103221(21) 10001136 , (01)00884838103221(21) 10001149 , (01)00884838103221(21) 10001150 , (01)00884838103221(21) 10001116 , (01)00884838103221(21) 10001109; Serial No. SN18000019, SN18000019, SN18000002, 721815121706, 10000015, SN18000014, 20000070, SN19000007, 10000035, 10000011, SN18000021, SN19000002, SN19000001, 10000021, 20000054, SN19000006, SN19000011, SN19000012, SN19000005, 10000051, 20000078, 10000050, 20000045, 10000008, SN19000018, 10000017, 10000045, SN19000017, SN19000014, 10000013, 10000010, 10000031, 10000030, 10000018, 10000024, 10000020, 10000025, 10000026, 10000028, SN10001008, 10000036, 10000037, 10000043, 20000026, SN10001004, 10000052, 20000051, 10001028, 10000040, 20000086, 20000052, 20000079, 20000068, 10001022, 20000089, 10001036, SN10001007, 10000023, SN10001002, 10001040, 10001046, 10001023, 10001027, 10001109, 10001026, 10001042, 10001044, 10001051, 20000063, 721815121708, 10001158, 10001158, 10001052, 10001098, 10001061, 10001074, 10001102, 10001060, 10001065, 10001059, 10001067, 10001073, 10001072, 10001089, 10001078, 10001075, 10001105, 10001093, 10001085, 10001101, 10001086, 10001100, 10001091, 10001121, 10001077, 10001096, 10001136, 10001149, 10001150, 10001116, 10001109.
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