The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1678-2026·Announced 2026-04-08

Philips Azurion 7 M20 X-ray may not start from foot switch

Philips has identified instances where X-ray imaging on the Azurion 7 M20 may not initiate, or may run intermittently, when the wired foot switch is used. 5,167 units are affected.

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: FDA Class II device recall describing a functional failure that could interrupt imaging during a procedure; no injuries are stated in the source, placing it at the risk-of-harm level rather than Severe.

Plain-English summary

Philips is recalling the Azurion 7 M20 interventional X-ray system, system codes 722079, 722224, 722234 and 722282 (the last of which was supplied outside the US only). The action covers 5,167 units, of which 1,728 were distributed in the United States and 3,439 internationally.

The firm identified instances in which X-ray imaging may not be initiated, or may occur intermittently, when the operator uses the wired foot switch. The FDA classified the action as Class II.

Distribution was nationwide in the United States and to a large number of international markets. The systems are used in hospital catheterisation and interventional radiology suites rather than sold to consumers.

Facilities operating an affected Azurion 7 M20 should follow the instructions issued by Philips and direct questions to the manufacturer or their Philips service representative.

The recalled product

Product
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional X-ray system
Hazard

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)

  • (1) System Code: 722079
  • UDI: 00884838085268
  • System Serial Number: 1023
  • 645
  • 646
  • 1013
  • 1387
  • 460
  • 35
  • 40
  • 43
  • 703307
  • 703904
  • 1048
  • 1137
  • 401
  • 1010
  • 1054
  • 266
  • 534

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 22 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 22 products in this recall →

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