The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2170-2026·Announced 2026-05-20

Philips Azurion X-Ray System Cable Hose Carriers May Loosen or Break

Bolts and plastic parts of cable hose carriers on Philips Azurion X-ray systems may loosen or break during monitor movement or rotation, potentially causing the cable hose to become unsecured.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The hazard is structural deterioration of fasteners and mounting components, and the source text explicitly does not report any injuries or illnesses. The hazard is potential/theoretical in nature.

Plain-English summary

Philips Azurion X-ray systems are being recalled because the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time. This deterioration can occur due to the forces applied when the monitor is moved or rotated.

Affected systems include multiple Azurion models: Azurion 3 (M12 and M15), Azurion 5 (standard, M12, and M20), Azurion 7 (standard, B12, B20, M12, and M20). A total of 1,718 units have been distributed worldwide, including to the United States and Canada.

Customers who operate these systems should inspect the cable hose carriers for any signs of loosening, cracking, or breakage. If damage is detected, they should contact Philips Medical Systems for service or replacement parts. Philips has issued this Class II recall to prevent potential safety risks associated with cable hose displacement.

The recalled product

Product
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20…
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Imaging Equipment / X-Ray System
Hazard
Affected units
1,718

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)

  • (01)00884838099203(21)178
  • (01)00884838099203(21)93]
  • 722229 [(01)00884838116726(21)22
  • (01)00884838116726(21)9
  • (01)00884838116726(21)16
  • (01)00884838116726(21)15
  • (01)00884838116726(21)5
  • (01)00884838116726(21)3
  • (01)00884838116726(21)4
  • (01)00884838116726(21)6
  • (01)00884838116726(21)2
  • (01)00884838099210(21)328
  • (01)00884838099210(21)389
  • (01)00884838099210(21)378
  • (01)00884838099210(21)243
  • (01)00884838099210(21)392
  • (01)00884838099210(21)396
  • (01)00884838099210(21)13
  • (01)00884838099210(21)379
  • (01)00884838099210(21)385

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

See all →

Similar recalls