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.
This recall has been terminated (originally issued August 15, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- July 25, 2012
- Posted
- August 15, 2012
- Terminated
- March 1, 2013
- Recall Number
- Z-2207-2012
- Quantity
- 7 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Essenta DR C-Arm may fall
Distribution
Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
Lot / Code Info
Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
Root Cause
Equipment maintenance
Action Taken
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.