Class II U.S. Food and Drug Administration

Philips Azurion system recall: Philips has identified two (2) software issues affecting device systems

Recall published 9 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1113-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Philips Medical Systems Nederland B.v.
Product type
Medical devices
Units affected
228 units (all OUS)
Distribution
Arkansas, Arizona, Colorado, Delaware, Idaho, Illinois, Indiana, Massachusetts, Missouri
Made in
Netherlands
Lot / code info
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;
UPC codes
00884838099203, 00884838099210, 00884838099241, 00884838099258, 00884838099265, 00884838099272, 00884838099227, 00884838099234, 00884838116726, 00884838116733, 00884838116740, 00884838116757, 00884838116764, 00884838116771, 00884838116788, 00884838116801

Products covered by this recall

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

Check your product

The notice names 52 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00884838099203
  • 00884838099210
  • 00884838099241
  • 00884838099258
  • 00884838099265
  • 00884838099272
  • 00884838099227
  • 00884838099234
  • 00884838116726
  • 00884838116733
  • 00884838116740
  • 00884838116757
  • 00884838116764
  • 00884838116771
  • 00884838116788
  • 00884838116801

Model or item number

On the rating label, the box or the instruction sheet.

  • 722221
  • 722222
  • 722223
  • 722224
  • 722225
  • 722226
  • 722227
  • 722228
  • 722229
  • 722230
  • 722231
  • 722232
  • 722233
  • 722234
  • 722235
  • 722236

Serial number

On the rating plate, often next to the date of manufacture.

  • 32
  • 40
  • 35
  • 31
  • 33
  • 25
  • 54
  • 50
  • 52
  • 55
  • 30
  • 63
  • 60
  • 67
  • 62
  • 14
  • 17
  • 66
  • 59
  • 69

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Philips Medical Systems Nederland B.v. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Veenpluis 4-6, Best

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Philips Medical Systems Nederland B.v. medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884838099203, 00884838099210, 00884838099241; model number 722221, 722222, 722223. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists Arkansas, Arizona, Colorado, Delaware, Idaho, Illinois, Indiana, Massachusetts, Missouri.

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