Philips Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0584-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command.

Product Classification:

Class II

Date Initiated: December 5, 2013

Date Posted: January 8, 2014

Recall Number: Z-0584-2014

Event ID: 67012

Reason for Recall:

X-ray system C-arm casting may loosen and fall

Status: Terminated

Product Quantity: 424 units

Code Information:

All Essenta DR x-ray Systems

Distribution Pattern:

Worldwide Distribution - USA (Nationwide) including Puerto Rico and the countries of : Afghanistan, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hungary, India, Indonesia Iran,Italy, Jordan, Kazakstan, Kenya, Liberia, Lithuania, Morocco, Netherlands, New Zealand, Nigeria, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Arab, United Kingdom and Viet nam.

Voluntary or Mandated:

Voluntary: Firm initiated