Agency classClass IIOur severity:Severe FDA (Devices)·Z-1933-2020·Announced 2020-05-20

Philips Zenition 70 Trolley Cable Recall for Electrical Contact Failure

Philips is recalling 25 Zenition 70 systems because strain relief loss on the trolley cable can break electrical contacts, exposing live parts.

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 significant risk of injury, which aligns with the 'Severe' criteria for significant injury reports or structural defects.

Plain-English summary

Philips North America, LLC is recalling 25 units of the Philips Zenition 70 (System code 718133) medical device. 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 may 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 affected units were distributed worldwide, including nationwide in the United States (specifically Maryland and Michigan) and in Austria, Belgium, France, Germany, Netherlands, Norway, South Africa, Spain, Switzerland, and the United Kingdom. Affected serial numbers are: 35, 37, 56, 20, 50, 2, 7, 8, 10, 12, 13, 47, 67, 34, 19, 31, 45, 86, 30, 59, 51, 21, and 54. Users should contact the manufacturer for instructions on how to proceed.

The recalled product

Product: Philips Zenition 70, System code 718133 - 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 — Radiology Equipment
Hazard: electric-shock
equipment-failure
Affected units: 25

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

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Same hazard · electric shock