Philips North America: Device Recall

Recall Details

Recall Number

Z-0597-2026

Classification

Class II

Product Type

Device

Recalling Firm

Philips North America

Status

Ongoing

Date Initiated

10/27/2025

Location

Cambridge, MA, United States

Voluntary/Mandated

FDA Mandated

Product Quantity

110

Reason for Recall

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

Product Description

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

Distribution Pattern

U.S.

Other Recalls by Philips North America

• Class II: Risk 12/22/2025
  A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
• Class II: Risk 12/03/2025
  The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
• Class II: Risk 12/03/2025
  The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
• Class II: Risk 12/03/2025
  The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
• Class II: Risk 12/03/2025
  The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

View all recalls by Philips North America →