Agency classClass IIOur severity:Severe FDA (Devices)·Z-1932-2020·Announced 2020-05-20

Philips Zenition 50 Medical Device Recalled for Electrical Contact Failure

Philips is recalling 25 Zenition 50 devices because strain relief loss can cause electrical contacts to break, potentially exposing live parts or losing the video signal.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a defect that can expose live electrical parts (230 V), posing a risk of significant injury (electric shock) or loss of critical video signal during procedures, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.

Plain-English summary

Philips North America, LLC is recalling 25 units of the Philips Zenition 50 (System code 718096). These devices are used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on patients other than neonates.

The recall is due to a defect where strain relief can be lost at the stand side of the Stand MVS Trolley Cable. Over time, pulling, twisting, or dropping the connector can cause one or more electrical contacts to break. If this occurs, live parts (230 V) may be exposed, or the video signal may be lost.

The devices were distributed worldwide, including nationwide in the United States (specifically Maryland and Michigan) and in Austria, Belgium, France, Germany, the Netherlands, Norway, South Africa, Spain, Switzerland, and the United Kingdom. Affected serial numbers are listed in the source metadata. Users should contact the manufacturer for instructions on repair or replacement.

The recalled product

Product: Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
Manufacturer: Philips North America, LLC
Category: Medical Device — Radiological Guidance
Hazard: electric-shock
signal-loss
Affected units: 25

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 (1)

Serial Numbers 17 7

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips North America, LLC 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 2 products in this recall →

Same manufacturer · Philips North America, LLC

See all →

High
Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
Moderate
Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
Moderate
Philips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
Moderate
Philips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Moderate
Philips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30

Same hazard · electric shock