Class II U.S. Food and Drug Administration

Philips Azurion Systems with software versions R2.1.10 and R2.2.10 recall: Six (6) identified software issues which may result in the following: system

Recall published 9 months ago

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

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-1091-2026
Published
January 21, 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
10,466 units
Distribution
Nationwide
Made in
Netherlands
Lot / code info
Software Versions: R2.1.10 and R2.2.10. 1. Model Number (UDI): 722063 ((01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)108, (01)00884838085275(21)153, (01)00884838085275(21)69, (01)00884838085275(21)154, (01)00884838085275(21)97, (01)00884838085275(21)137, (01)00884838085275(21)116, (01)00884838085275(21)127, (01)00884838085275(21)151, (01)00884838085275(21)148, (01)00884838085275(21)150, (01)00884838085275(21)146, (01)00884838085275(21)149, (01)00884838085275(21)123, (01)00884838085275(21)130, (01)00884838085275(21)143, (01)00884838085275(21)139, (01)00884838085275(21)144, (01)00884838085275(21)145, (01)00884838085275(21)141, (01)00884838085275(21)140, (01)00884838085275(21)135, (01)00884838085275(21)133, (01)00884838085275(21)107, (01)00884838085275(21)120, (01)00884838085275(21)129, (01)00884838085275(21)105, (01)00884838085275(21)110, (01)00884838085275(21)128, (01)00884838085275(21)119, (01)00884838085275(21)113, (01)00884838085275(21)43, (01)00884838085275(21)117, (01)00884838085275(21)115, (01)00884838085275(21)101, (01)00884838085275(21)94, (01)00884838085275(21)106, (01)00884838085275(21)103, (01)00884838085275(21)99, (01)00884838085275(21)102, (01)00884838085275(21)104, (01)00884838085275(21)100, (01)00884838085275(21)80, (01)00884838085275(21)81, (01)00884838085275(21)89, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)82, (01)00884838085275(21)87, (01)00884838085275(21)93, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)79, (01)00884838085275(21)83, (01)00884838085275(21)76, (01)00884838085275(21)77, (01)00884838085275(21)78, (01)00884838085275(21)70, (01)00884838085275(21)53, (01)00884838085275(21)72, (01)00884838085275(21)63, (01)00884838085275(21)71, (01)00884838085275(21)73, (01)00884838085275(21)62, (01)00884838085275(21)50, (01)00884838085275(21)59, (01)00884838085275(21)54, (01)00884838085275(21)61, (01)00884838085275(21)52, (01)00884838085275(21)55, (01)00884838085275(21)40, (01)00884838085275(21)51, (01)00884838085275(21)48, (01)00884838085275(21)47, (01)00884838085275(21)46, (01)00884838085275(21)44, (01)00884838085275(21)41, (01)00884838085275(21)38, (01)00884838085275(21)29, (01)00884838085275(21)27, (01)00884838085275(21)28, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)26, (01)00884838085275(21)25, (01)00884838085275(21)30, (01)00884838085275(21)21, (01)00884838085275(21)24, (01)00884838085275(21)22, (01)00884838085275(21)19, (01)00884838085275(21)23, (01)00884838085275(21)18, (01)00884838085275(21)17, (01)00884838085275(21)15, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)3, (01)00884838085275(21)2, (01)00884838085275(21)4, (01)00884838085275(21)121), 722221 ((01)00884838099203(21)181, (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838099203(21)178, (01)00884838099203(21)54, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)177, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)171, (01)00884838099203(21)153, (01)00884838099203(21)108, (01)00884838099203(21)207, (01)00884838099203(21)208, (01)00884838099203(21)198, (01)00884838099203(21)193, (01)00884838099203(21)194, (01)00884838099203(21)205, (01)00884838099203(21)203, (01)00884838099203(21)202, (01)00884838099203(21)195, (01)00884838099203(21)196, (01)00884838099203(21)197, (01)00884838099203(21)190, (01)00884838099203(21)146, (01)00884838099203(21)186, (01)00884838099203(21)35, (01)00884838099203(21)43, (01)00884838099203(21)180, (01)00884838099203(21)187, (01)00884838099203(21)182, (01)00884838099203(21)185, (01)00884838…
UPC codes
00884838085275, 00884838099203

Products covered by this recall

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

Check your product

The notice names 9 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.

  • 00884838085275
  • 00884838099203

Model or item number

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

  • 722064
  • 722222
  • 722228
  • 722068
  • 722079
  • 722224
  • 722282. — Software Versions

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. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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?

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error. Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884838085275, 00884838099203; model number 722064, 722222, 722228. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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