DigitalDiagnost 4 Flex/Value recall
DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Why was DigitalDiagnost 4 Flex/Value recalled?
Potential for units suspended on the ceiling to fail and fall.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
- Recalling firm
- Philips North America Llc
- Quantity
- 92 units
- Distribution
- Nationwide distribution.
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)