Z-2207-2012Class II

Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a...

Name: Z-2207-2012 Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a...
Creator: Philips Healthcare Inc.
Published: 2012-07-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-07-25 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling)... on 2012-07-25. FDA classified it as Class II and gives the reason as "Essenta DR C-Arm may 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-2207-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-25
Posted: 2012-08-15
Terminated: 2013-03-01
Recalling firm: Philips North America LLC
Product: Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): 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 arm.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Essenta DR C-Arm may fall
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Philips Medical sent an "URGENT FIELD SAFETY NOTICE" dated July 09, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers are asked to inspect the C-Arm unit and discontinue use if not parallel to the column, do not use the system and call for a Service Technician. A Field Change Order (FCO) is being released that requires an inspection of C-ARM connection and, if necessary, repair of systems. The bolts will be disconnected and thread inserts will be checked. If not the thread inserts are no longer secured, additional holes will be drilled to use in place of the original ones. For further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377.
Quantity in commerce: 7 units
Distribution: Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
Product codes and lots: Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2207-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2207-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-15

Product code KPR

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)