The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

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