medical Class II Updated 2023-11-15

Philips North America Llc recalls CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

Recalled Product

CombiDiagnost R90, 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. 709030 and 709031; UDI: (01)00884838076747(21) SN17000014 , (01)00884838076747(21) 10000020 , (01)00884838076747(21) SN17000130 , (01)00884838076747(21) SN17000123 , (01)00884838076747(21) SN18000021 , (01)00884838076747(21) SN18000001 , (01)00884838076747(21) SN18000075 , (01)00884838076747(21) SN18000002 , (01)00884838076747(21) 10000004 , (01)00884838076747(21) SN17000144 , (01)00884838076747(21) SN17000140 , (01)00884838076747(21) SN18000003 , (01)00884838076747(21) SN18000063 , (01)00884838076747(21) SN18000018 , (01)00884838076747(21) SN18000022 , (01)00884838076747(21) SN18000041 , (01)00884838076747(21) SN18000031 , (01)00884838076747(21) 10001097 , (01)00884838076747(21) 10000056 , (01)00884838076747(21) 28 , (01)00884838076747(21) 10000184 , (01)00884838076747(21) SN19000018 , (01)00884838076747(21) SN19000006 , (01)00884838076747(21) SN19000040 , (01)00884838076747(21) SN19000001 , (01)00884838076747(21) SN19000041 , (01)00884838076747(21) 10000051 , (01)00884838076747(21) 10000000 , (01)00884838076747(21) 10000087 , (01)00884838076747(21) 10001095 , (01)00884838076747(21) 10000122 , (01)00884838076747(21) 10001001 , (01)00884838076747(21) 10000145 , (01)00884838076747(21) 10000152 , (01)00884838076747(21) 10000190 , (01)00884838076747(21) 10001076 , (01)00884838076747(21) SN17000153 , (01)00884838101456(21) 10001054 , (01)00884838101456(21) 10001087 , (01)00884838101456(21) 10001086 , (01)00884838101456(21) 10001159 , (01)00884838101456(21) 10001109 , (01)00884838101456(21) 10001114 , (01)00884838101456(21) 10001171 , (01)00884838101456(21) 10001194 , (01)00884838101456(21) 10001193; Serial No. SN17000014, 10000020, SN17000130, SN17000123, SN18000021, SN18000001, SN18000075, SN18000002, 10000004, SN17000144, SN17000140, SN18000003, SN18000063, SN18000018, SN18000022, SN18000041, SN18000031, 10001097, 10000056, 28, 10000184, SN19000018, SN19000006, SN19000040, SN19000001, SN19000041, 10000051, 10000000, 10000087, 10001095, 10000122, 10001001, 10000145, 10000152, 10000190, 10001076, SN17000153, 10001054, 10001087, 10001086, 10001159, 10001109, 10001114, 10001171, 10001194, 10001193.
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