Z-0273-2024 Class II Ongoing
FDA device recall Z-0273-2024 was initiated by Philips North America Llc on September 21, 2023 and is designated Class II. Reason for recall: Potential for units suspended on the ceiling to fail and fall. The recall status is ongoing. Affected quantity: 92 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- September 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92 units
Product Description
DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Reason for Recall
Potential for units suspended on the ceiling to fail and fall.
Distribution Pattern
Nationwide distribution.
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.