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RecallWatchMedical Device Safety
Class IIOngoingZ-1113-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported Jan 28, 2026 · 7 months ago
Legal News Analyst ·

Reason for recall

Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Philips Azurion system; Software Version Number: R3.1;

Lot / code information

Model
722221; System Product Name: Azurion 3 M12
UDI
00884838099203
Serial #
(2)
Model
722222; System Product Name: Azurion 3 M15
UDI
00884838099210
Serial #
(3)
Model
722223; System Product Name: Azurion 7 M12
UDI
00884838099241
Serial #
(4)
Model
722224; System Product Name: Azurion 7 M20
Show 38 more code fields
UDI
00884838099258
Serial #
(5)
Model
722225; System Product Name: Azurion 7 B12
UDI
00884838099265
Serial #
(6)
Model
722226; System Product Name: Azurion 7 B20
UDI
00884838099272
Serial #
(7)
Model
722227; System Product Name: Azurion 5 M12
UDI
00884838099227
Serial #
(8)
Model
722228; System Product Name: Azurion 5 M20
UDI
00884838099234
Serial #
(9)
Model
722229; System Product Name: Azurion 3 M12
UDI
00884838116726
Serial #
5, 9, 32, 40, 35, 31, 33; (10)
Model
722230; System Product Name: Azurion 3 M15
UDI
00884838116733
Serial #
25, 54, 50, 52, 55, 30, 63, 60, 67; (11)
Model
722231; System Product Name: Azurion 5 M12
UDI
00884838116740
Serial #
62, 7, 8, 14, 17, 63, 6, 66, 59, 69, 56, 67, 48, 68, 80, 93, 87, 94, 81, 92, 18; (12)
Model
722232; System Product Name: Azurion 5 M20
UDI
00884838116757
Serial #
97, 39, 31, 100, 104, 93, 115, 113, 118, 119, 89, 54, 67, 7, 128, 86, 110, 132, 130, 131, 123, 137, 139, 117, 260; (13)
Model
722233; System Product Name: Azurion 7 M12
UDI
00884838116764
Serial #
239, 100, 233, 240, 176, 227, 223, 130, 161, 194, 243, 56, 193, 280, 75, 253, 156, 288, 72, 281, 304, 300, 105, 295, 312, 310, 285, 292, 290, 298, 297; (14)
Model
722234; System Product Name: Azurion 7 M20
UDI
00884838116771
Serial #
731, 727, 261, 473, 683, 722 — +79 moreShow all
731, 727, 261, 473, 683, 722, 562, 750, 745, 766, 265, 701, 400, 310, 421, 314, 182, 579, 96, 763, 272, 612, 15, 844, 105, 702, 751, 384, 851, 869, 743, 337, 651, 455, 706, 312, 563, 709, 764, 871, 846, 278, 713, 802, 868, 277, 742, 184, 819, 759, 910, 928, 415, 414, 945, 961, 355, 933, 692, 920, 569, 939, 909, 553, 837, 856, 571, 756, 941, 570, 761, 981, 353, 888, 964, 820, 746, 736, 876, 599, 1017, 908, 487, 983, 495; (15)
Model
722235; System Product Name: Azurion 7 B12
UDI
00884838116788
Serial #
96, 79, 111, 100, 101, 38, 27, 92, 78, 118, 48, 131, 135, 22, 125, 103, 138, 139, 137; (16)
Model
722236; System Product Name: Azurion 7 B20
UDI
00884838116801
Serial #
241, 297, 198, 215, 305, 274, 299, 78, 279, 287, 318, 353, 324, 331, 293, 245, 314, 310, 317, 312, 77, 358, 206, 383, 380, 370, 377, 385, 405, 379, 328

What the firm is doing

On December 12, 2025, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: - Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issues. " In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. " Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. " Complete and return the response form included in this Urgent Medical Device Correction letter to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issues and required actions to be taken. " If you experience an issue described in this letter, please report it to your local Philips representative. Actions planned by Philips IGT Systems to correct the issues Philips will address the identified issues by implementing software updates in all affected systems. Philips expects to have software update 3.1.5 (FCO72200635, FC072200671), that resolves issues 1, released by Q1 2026 (subject to regulatory clearance). The Longitudinal Position Error (issue 2) will not be resolved with software update 3.1.5. The solution for this issue is planned for Q4 2026 (subject to regulatory clearance) with software update 3.1.15 (FCO72200684). Your local Philips representative will contact you to schedule visits to install the software updates once available.

DistributionShow details

International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA;

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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