Philips Medical Systems Nederland B.V.: Medical Device Recall in 2025 - (Recall #: Z-1583-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

Product Classification:

Class II

Date Initiated: July 20, 2023

Date Posted: April 30, 2025

Recall Number: Z-1583-2025

Event ID: 96598

Reason for Recall:

Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.

Status: Ongoing

Product Quantity: 12 systems

Code Information:

Zenition 70

Distribution Pattern:

US Nationwide distribution

Voluntary or Mandated:

FDA Mandated