PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands Azurion 7 M20. X-ray Image guided Therapy System. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Azurion 7 M20. X-ray Image guided Therapy System.
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Lot Codes / Batch Numbers
Model No.: 722079, 722224, UDI-DI: (01)00884838085268(21), (01)00884838099258(21), System Equipment Number: 69991047, 69991048, 71927518, 71929379, 71929381, 71929386, 71934809, 71935340, 71937626, 71939045, 71957323, 72045694, 72150041, 72173543, 72273457, 72312081, 72321356, 72327897, 72400707, 72414989, 72419144, 72426402, 72648857, 72719305, 72719820, 72721959, 72748229, 72771284, 72805530, 72933546, 73000862, 73003437, 73011242, 73051857, 73337310, 73337321, 73339454, 73340554, 73407813, 73461447, 73516696, 73581917, 73581968, 73616732, 73625357, 73633104, 73717291, 73861967, 74017556, 74020682, 74095702, 74154690, 74154691, 74155276, 74169049, 74227230, 74227231, 74238084, 74250404, 74288937, 74298715, 74369399, 74465159, 74517090, 74582619, 74592051, 74593412, 74608935, 74609935, 74610486, 74610632, 74611953, 74613538, 74620302, 74620341, 74697609, 74817549, 74879566, 74896878, 75215416, 75387595, 75390578, 75434973, 75551701, 75581576, 75610667, 75635433, 75714884, 75844170, 75852749, 75855479, 75935287, 76078970, 76091821, 76138290, 76417103, 76479323, 76515054, 76553358, 76577152, 76787680, 76891085, 77121963, 77427180, 77530081, 77654726, 77654982, 77777427, 77779946, 77970791, 77970948, 77992050, 78105115, 78248928, 78294148, 78301055, 78397953, 78566369, 78742461, 78871714, 78951530, 79075848, 79092310, 79109133, 79112403, 79170704, 79221166, 79260136, 79386139, 79721725, 79755150, 79871193, 80031529, 80162299, 80389257, 80518631, 80634403, 80757669, 80864517, 80909985, 81158245, 81198118, 81435812, 81576136, 81585676, 82061620, 82084127, 83171264, 83616043, 84187167, 84817818, 86188742, 86497093, 86714680, 86796686, 87030322, 87184700, 87490196, 88006565, 88182534, 88520522, 88806300, 89171879, 89418260, 91702038, 92145971, 92904015, 93089744, 93184693, 93338682, 93496319, 93571818, 93617781, 93640291, 94453083, 94693032, 95022475, 95133121, 95182889, 95492390, 95747223, 95747224, 96447199, 96449972, 97171402, 97171408, 97385374, 97640203, 98542276, 98862191, 99584876
Products Sold
Model No.: 722079, 722224; UDI-DI: (01)00884838085268(21), (01)00884838099258(21); System Equipment Number: 69991047, 69991048, 71927518, 71929379, 71929381, 71929386, 71934809, 71935340, 71937626, 71939045, 71957323, 72045694, 72150041, 72173543, 72273457, 72312081, 72321356, 72327897, 72400707, 72414989, 72419144, 72426402, 72648857, 72719305, 72719820, 72721959, 72748229, 72771284, 72805530, 72933546, 73000862, 73003437, 73011242, 73051857, 73337310, 73337321, 73339454, 73340554, 73407813, 73461447, 73516696, 73581917, 73581968, 73616732, 73625357, 73633104, 73717291, 73861967, 74017556, 74020682, 74095702, 74154690, 74154691, 74155276, 74169049, 74227230, 74227231, 74238084, 74250404, 74288937, 74298715, 74369399, 74465159, 74517090, 74582619, 74592051, 74593412, 74608935, 74609935, 74610486, 74610632, 74611953, 74613538, 74620302, 74620341, 74697609, 74817549, 74879566, 74896878, 75215416, 75387595, 75390578, 75434973, 75551701, 75581576, 75610667, 75635433, 75714884, 75844170, 75852749, 75855479, 75935287, 76078970, 76091821, 76138290, 76417103, 76479323, 76515054, 76553358, 76577152, 76787680, 76891085, 77121963, 77427180, 77530081, 77654726, 77654982, 77777427, 77779946, 77970791, 77970948, 77992050, 78105115, 78248928, 78294148, 78301055, 78397953, 78566369, 78742461, 78871714, 78951530, 79075848, 79092310, 79109133, 79112403, 79170704, 79221166, 79260136, 79386139, 79721725, 79755150, 79871193, 80031529, 80162299, 80389257, 80518631, 80634403, 80757669, 80864517, 80909985, 81158245, 81198118, 81435812, 81576136, 81585676, 82061620, 82084127, 83171264, 83616043, 84187167, 84817818, 86188742, 86497093, 86714680, 86796686, 87030322, 87184700, 87490196, 88006565, 88182534, 88520522, 88806300, 89171879, 89418260, 91702038, 92145971, 92904015, 93089744, 93184693, 93338682, 93496319, 93571818, 93617781, 93640291, 94453083, 94693032, 95022475, 95133121, 95182889, 95492390, 95747223, 95747224, 96447199, 96449972, 97171402, 97171408, 97385374, 97640203, 98542276, 98862191, 99584876,
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands is recalling Azurion 7 M20. X-ray Image guided Therapy System. due to The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Recommended Action
Per FDA guidance
Customers were mailed a recall notification dated 6/8/23 notifying them of this medical device correction. Customers are asked to retain the correction notice until all on-site are corrected, ensuring they are available to those who operate the device. If cracks in the FlexMove Carriage and/or abnormal noise during transversal movements of the C-Arc are observed, customers are to contact Philips so their field inspection may be prioritized. A diagram of crack locations on the FlexMove Carriage was provided for user reference. Customers are asked to return the provided Response Form no later than 30 days from receipt. Philips will contact customers to schedule a visit to inspect on-site systems and coordinate replacement of the affected bolts and/or FlexMove Carriage, as needed. Customers with any questions may contact Customer Care Solutions at 1-800-722-9377. Philips sent an updated notification to customers on 11/15/2024 with updated information regarding continued use and actions planned by Philips. Systems may be safely continuing to be sued for at least three (3) years after completing the inspectional activities described in the Correction and Removal Actions of the provided letter and Philips will contact customers to schedule a visit to install the permanent solution ensuring that it is implemented within 3 years after the initial inspectional activities or after installation. The permanent solution expected to be available by December 2024. Customers were also instructed to complete and return the Response Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026