Reported Apr 30, 2025 · Ongoing

Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as…

Philips Medical Systems Nederland B.V.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems Nederland B.V. · High Tech Campus 36 · Eindhoven, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • Zenition 70
Amount recalled
12 systems

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.