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Azurion recallZ-2284-2023 · Philips Medical Systems Nederland B.V. · initiated Jun 12, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-2284-2023
Status
Open, Classified
Initiated by the company
Jun 12, 2023
Posted by the FDA
Aug 2, 2023
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
648 units
Product code
OWB
FDA submissions
K200917
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kenya, South Korea, Libya, Lithuania, Malaysia, Maldives, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Vietnam.

Product description

Azurion 7 M20. X-ray Image guided Therapy System.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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,

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92635).

Sources and updates

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