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Recall Observatory FDA recall evidence

Device product

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

Z-0273-2024

September 21, 2023

Class II

Product summary

Firm
Philips North America Llc
Event
Event 93200
Status
Ongoing
Classification
Class II
Quantity
92 units
Official record key
device-enforcement:Z-0273-2024

Official wording

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

Code information: 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.

Distribution pattern: Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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