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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98108

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 12, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1113-2026
Recall number
Z-1113-2026
Initiated
December 12, 2025
Classification
Class II
Status
Ongoing
Quantity
228 units (all OUS)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issues affecting device systems that may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Software Version Number: R3.1; (1) Model Number: 722221; System Product Name: Azurion 3 M12; UDI-DI: 00884838099203; Serial Numbers: (2) Model Number: 722222; System Product Name: Azurion 3 M15; UDI-DI: 00884838099210; Serial Numbers: (3) Model Number: 722223; System Product Name: Azurion 7 M12; UDI-DI: 00884838099241; Serial Numbers: (4) Model Number: 722224; System Product Name: Azurion 7 M20; UDI-DI: 00884838099258; Serial Numbers: (5) Model Number: 722225; System Product Name: Azurion 7 B12; UDI-DI: 00884838099265; Serial Numbers: (6) Model Number: 722226; System Product Name: Azurion 7 B20; UDI-DI: 00884838099272; Serial Numbers: (7) Model Number: 722227; System Product Name: Azurion 5 M12; UDI-DI: 00884838099227; Serial Numbers: (8) Model Number: 722228; System Product Name: Azurion 5 M20; UDI-DI: 00884838099234; Serial Numbers: (9) Model Number: 722229; System Product Name: Azurion 3 M12; UDI-DI: 00884838116726; Serial Numbers: 5, 9, 32, 40, 35, 31, 33; (10) Model Number: 722230; System Product Name: Azurion 3 M15; UDI-DI: 00884838116733; Serial Numbers: 25, 54, 50, 52, 55, 30, 63, 60, 67; (11) Model Number: 722231; System Product Name: Azurion 5 M12; UDI-DI: 00884838116740; Serial Numbers: 62, 7, 8, 14, 17, 63, 6, 66, 59, 69, 56, 67, 48, 68, 80, 93, 87, 94, 81, 92, 18; (12) Model Number: 722232; System Product Name: Azurion 5 M20; UDI-DI: 00884838116757; Serial Numbers: 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 Number: 722233; System Product Name: Azurion 7 M12; UDI-DI: 00884838116764; Serial Numbers: 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 Number: 722234; System Product Name: Azurion 7 M20; UDI-DI: 00884838116771; Serial Numbers: 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 Number: 722235; System Product Name: Azurion 7 B12; UDI-DI: 00884838116788; Serial Numbers: 96, 79, 111, 100, 101, 38, 27, 92, 78, 118, 48, 131, 135, 22, 125, 103, 138, 139, 137; (16) Model Number: 722236; System Product Name: Azurion 7 B20; UDI-DI: 00884838116801; Serial Numbers: 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;

Distribution pattern

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;