High FDA (Devices)·Z-0584-2014·Announced 2014-01-08

Philips Essenta DR X-ray System C-arm Casting Recall

Philips is recalling 424 Essenta DR stationary X-ray systems because the C-arm casting may loosen and fall.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling heavy machinery component) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Philips Medical Systems, Inc. is recalling 424 units of the Essenta DR stationary X-ray system, model 712070. The recall was initiated because the C-arm casting on the device may loosen and fall.

The affected units were distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous international countries. The Essenta DR is a multifunctional stationary X-ray system designed for radiographic examination of recumbent, standing, or seated patients.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Users should be aware of the potential for the C-arm casting to detach from the unit.

The recalled product

Product: Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiograp
Manufacturer: Philips Medical Systems, Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: falling-object
Affected units: 424

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)

All Essenta DR x-ray Systems

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Philips Medical Systems, Inc.

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