Z-0584-2014Class II

Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional...

Name: Z-0584-2014 Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional...
Creator: Philips Medical Systems, Inc.
Published: 2013-12-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-12-05 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems, Inc. began a recall of 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... on 2013-12-05. FDA classified it as Class II and gives the reason as "X-ray system C-arm casting may loosen and fall". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0584-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Posted: 2013-12-27
Terminated: 2017-01-17
Recalling firm: Philips North America LLC
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 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 code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: X-ray system C-arm casting may loosen and fall
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Medical Systems issued a Urgent Field Safety Notice-Warning Label and Inspection, dated November 21, 2013, advising of potential of C-arm detaching and requesting a daily inspection and a safety warning label . If you need any further information or support concerning this issue, please contact your local Philips representative. 1-800-722-9377.
Quantity in commerce: 424 units
Distribution: 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.
Product codes and lots: All Essenta DR x-ray Systems

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0584-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0584-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27

Product code MQB

K070528Class IIPhilips Essenta DrPhilips Medical Systems GmbH, Dmc / cleared 2007-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)