The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2931-2026·Announced 2026-08-19

Philips Azurion Rystem X-Ray System Software Recall for Image Quality Issues

Philips is recalling Azurion Rystem X-ray systems due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (procedural complications and inappropriate treatment) without reported injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 10,872 units of the Philips Azurion Rystem Interventional Fluoroscopic X-Ray System. The affected units are specific model numbers (722063 through 722282) running software versions R2.2.10 and R2.1.10. These systems were distributed worldwide.

The recall is due to two software-related issues. The first issue involves potential image quality degradation, which may lead to a delay of therapy, procedural complications, and/or inappropriate treatment. The second issue involves the potential loss of geometry movements, which may lead to a delay of therapy and procedural complications.

Hospitals and medical facilities using these specific models and software versions should contact Philips for further instructions on how to address the software defects.

The recalled product

Product
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*…
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional Fluoroscopic X-Ray System
Hazard
Affected units
10,872

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distribution scope not specified by the agency.

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