medical Class II Updated 2023-11-15

Philips North America Llc recalls DigitalDiagnost 4 Flex/Value, used to acquire, process, stor

Recalled Product

DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.

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. 712028, 712227, & 712032; UDI: (01)00884838074514(21)SN18000410, (01)00884838074514(21)SN18000253, (01)00884838074514(21)SN18000339, (01)00884838074514(21)SN18000332, (01)00884838074514(21)SN18000448, (01)00884838074514(21)SN18000306, (01)00884838074514(21)SN18000397, (01)00884838074514(21)SN18000366, (01)00884838074514(21)SN18000391, (01)00884838074514(21)SN18000431, (01)00884838074514(21)SN19000191, (01)00884838074514(21)SN19000119, (01)00884838074514(21)SN19000217, (01)00884838074514(21)SN19000109, (01)00884838074514(21)SN19000260, (01)00884838074514(21)SN20000159, (01)00884838074514(21)SN19000328, (01)00884838074514(21)SN20000372, (01)00884838074514(21)SN20000277, (01)00884838074514(21)SN20000003, (01)00884838074514(21)SN20000052, (01)00884838074514(21)SN19000321, (01)00884838074514(21)SN20000039, (01)00884838074514(21)SN20000121, (01)00884838074514(21)SN18000024 , (01)00884838074514(21) SN15000304 , (01)00884838074514(21) SN15000283 , (01)00884838074514(21) SN15000252 , (01)00884838074514(21) SN15000255 , (01)00884838074514(21) SN18000274 , (01)00884838074514(21) SN16000009 , (01)00884838074514(21) SN16000036 , (01)00884838074514(21) SN16000262 , (01)00884838074514(21) SN17000002 , (01)00884838074514(21) SN16000249 , (01)00884838074514(21) SN17000357 , (01)00884838074514(21) SN18000035 , (01)00884838074514(21) SN17000389 , (01)00884838074514(21) SN17000058 , (01)00884838074514(21) SN16000008 , (01)00884838074514(21) SN17000122 , (01)00884838074514(21) SN17000027 , (01)00884838074514(21) SN17000125 , (01)00884838074514(21) SN17000083 , (01)00884838074514(21) SN17000103 , (01)00884838074514(21) SN17000110 , (01)00884838074514(21) SN17000171 , (01)00884838074514(21) SN17000241 , (01)00884838074514(21) SN18000157 , (01)00884838074514(21) SN18000105 , (01)00884838074514(21) SN18000244 , (01)00884838074514(21) SN17000326 , (01)00884838074514(21) SN17000372 , (01)00884838074514(21) SN18000142 , (01)00884838074514(21) SN18000048 , (01)00884838074514(21) SN18000106 , (01)00884838074514(21) SN18000085 , (01)00884838074514(21) SN18000202 , (01)00884838074514(21) SN18000040 , (01)00884838074514(21) SN17000239 , (01)00884838074514(21) SN18000066 , (01)00884838074514(21) SN18000149 , (01)00884838074514(21) SN18000140 , (01)00884838074514(21) SN20000222 , (01)00884838074514(21) 10001088 , (01)00884838074514(21) SN20000169 , (01)00884838074514(21) SN20000075 , (01)00884838074514(21) E1876E3421250195 , (01)00884838074514(21) SN20000223 , (01)00884838074514(21) SN20000342 , (01)00884838074514(21) SN20000397 , (01)00884838074514(21) 10001069 , (01)00884838074514(21) 10001063 , (01)00884838074514(21) SN10001030 , (01)00884838074514(21) SN10001031 , (01)00884838074514(21) SN10001024 , (01)00884838074514(21) 10001094 , (01)00884838074514(21) 10001066 , (01)00884838074514(21) 10001074 , (01)00884838074514(21) 10001071 , (01)00884838074514(21) 10001095 , (01)00884838074514(21) 19000319 , (01)00884838074514(21) 19000321 , (01)00884838074514(21) 19000322 , (01)00884838074514(21) 19000323 , (01)00884838074514(21) SN1600191 , (01)00884838074514(21) 19000328 , (01)00884838074514(21) 19000331; Serial No. SN15000418, SN15000397, SN18000410, SN18000253, SN18000339, SN18000332, SN18000448, SN18000306, SN18000397, SN18000366, SN18000391, SN18000431, SN19000191, SN19000119, SN19000217, SN19000109, SN19000260, SN20000159, SN19000328, SN20000372, SN20000277, SN20000003, SN20000052, SN19000321, SN20000039, SN20000121, SN18000024, SN15000304, SN15000283, SN15000252, SN15000255, SN18000274, SN16000009, SN16000036, SN16000262, SN17000002, SN16000249, SN17000357, SN18000035, SN17000389, SN17000058, SN16000008, SN17000122, SN17000027, SN17000125, SN17000083, SN17000103, SN17000110, SN17000171, SN17000241, SN18000157, SN18000105, SN18000244, SN17000326, SN17000372, SN18000142, SN18000048, SN18000106, SN18000085, SN18000202, SN18000040, SN17000239, SN18000066, SN18000149, SN18000140, SN20000222, 10001088, SN20000169, SN20000075, E1876E3421250195, SN20000223, SN20000342, SN20000397, 10001069, 10001063, SN10001030, SN10001031, SN10001024, 10001094, 10001066, 10001074, 10001071, 10001095, 19000319, 19000321, 19000322, 19000323, SN1600191, 19000328, 19000331, SN18862009, SN18862007.
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