Class II U.S. Food and Drug Administration

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067 recall: Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential

Recall published 2 months ago

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

The hazard: Potency, impurity or stability failure

The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

What the notice says: Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2931-2026
Published
August 19, 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
10872 units
Made in
Netherlands
Lot / code info
UDI: (01)00884838099258(21)1229, (01)00884838099258(21)450, (01)00884838085251(21)302, (01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)1578, (01)00884838099241(21)324, (01)00884838099241(21)585, (01)00884838099241(21)332, (01)00884838099258(21)750, (01)00884838099241(21)312, (01)00884838099241(21)85, (01)00884838099258(21)409, (01)00884838085268(21)1023, (01)00884838099272(21)125, (01)00884838099272(21)127, (01)00884838099272(21)126, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099258(21)295, (01)00884838099272(21)124, (01)00884838099272(21)120, (01)00884838099258(21)277, (01)00884838099258(21)262, (01)00884838099258(21)261, (01)00884838099258(21)272, (01)00884838099258(21)275, (01)00884838085367(21)547, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838085251(21)585, (01)00884838099258(21)1315, (01)00884838085268(21)645, (01)00884838085251(21)410, (01)00884838085268(21)646, (01)00884838099258(21)3526, (01)00884838099258(21)2744, (01)00884838099258(21)3698, (01)00884838099258(21)959, (01)00884838099258(21)381, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838099258(21)1371, (01)00884838099241(21)533, (01)00884838085268(21)1387, (01)00884838099272(21)153, (01)00884838099258(21)1019, (01)00884838085268(21)460, (01)00884838099258(21)260, (01)00884838085251(21)753, (01)00884838085268(21)35, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838099272(21)67, (01)00884838099258(21)1049, (01)00884838099258(21)3045, (01)00884838099258(21)3044, (01)00884838099258(21)3107, (01)00884838099258(21)2258, (01)00884838099258(21)1484, (01)00884838099272(21)209, (01)00884838099258(21)2573, (01)00884838099258(21)3514, (01)00884838099258(21)1083, (01)00884838099258(21)3314, (01)00884838085268(21)703307, (01)00884838099258(21)2436, (01)00884838099258(21)2184, (01)00884838099241(21)479, (01)00884838099272(21)271, (01)00884838099241(21)189, (01)00884838099258(21)246, (01)00884838085251(21)523, (01)00884838099241(21)1038, (01)00884838099241(21)47, (01)00884838099258(21)475, (01)00884838099241(21)1146, (01)00884838085268(21)703904, (01)00884838099258(21)1810, (01)00884838085268(21)890, (01)00884838099265(21)104, (01)00884838099258(21)762, (01)00884838099258(21)3153, (01)00884838085251(21)840, (01)00884838085251(21)293, (01)00884838099258(21)526, (01)00884838099258(21)2241, (01)00884838099258(21)588, (01)00884838099258(21)469, (01)00884838099272(21)675, (01)00884838099258(21)962, (01)00884838085268(21)1137, (01)00884838085268(21)1048, (01)00884838099241(21)352, (01)00884838099258(21)539, (01)00884838085350(21)221, (01)00884838099258(21)421, (01)00884838085350(21)42, (01)00884838085350(21)172, (01)00884838085350(21)173, (01)00884838099258(21)288, (01)00884838085268(21)401, (01)00884838099265(21)153, (01)00884838099241(21)391, (01)00884838085367(21)467, (01)00884838099272(21)112, (01)00884838099258(21)90, (01)00884838085268(21)1054, (01)00884838085268(21)1010, (01)00884838085367(21)178, (01)00884838085268(21)536, (01)00884838085268(21)534, (01)00884838085268(21)535, (01)00884838085268(21)266, (01)00884838099258(21)2784, (01)00884838099258(21)1635, (01)00884838085367(21)335, (01)00884838099258(21)50, (01)00884838085282(21)209, (01)00884838085251(21)291, (01)00884838099258(21)239, (01)00884838099258(21)2520, (01)00884838099258(21)589, (01)00884838085268(21)818, (01)00884838099258(21)91, (01)00884838099210(21)332, (01)00884838085268(21)412, (01)00884838099258(21)2945, (01)00884838099258(21)1556, (01)00884838099258(21)840, (01)00884838085268(21)617, (01)00884838099241(21)328, (01)00884838099258(21)362, (01)00884838099258(21)43, (01)00884838099258(21)1869, (01)00884838099241(21)681, (01)00884838099272(21)1091, (01)00884838099272(21)1052, (01)00884838099258(21)1564, (01)00884838085268(21)246, (01)00884838085268(21)488, (01)00884838085268(21)53, (01)00884838085268(21)57, (01)00884838099258(21)1692, (01)00884838085268(21)905, (01)008848380…
UPC codes
00884838099258, 00884838085251, 00884838099241, 00884838085268, 00884838099272, 00884838085367, 00884838099265, 00884838085350, 00884838085282, 00884838099210

Products covered by this recall

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System

Check your product

The notice names 17 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.

  • 00884838099258
  • 00884838085251
  • 00884838099241
  • 00884838085268
  • 00884838099272
  • 00884838085367
  • 00884838099265
  • 00884838085350
  • 00884838085282
  • 00884838099210

Model or item number

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

  • 722063
  • 722064
  • 722067
  • 722068
  • 722078
  • 722079
  • 722

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 Potency

Philips Medical Systems Nederland B.v. — The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  3. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  4. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Veenpluis 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?

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884838099258, 00884838085251, 00884838099241; model number 722063, 722064, 722067. 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?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Related recalls