Reported Aug 22, 2012 · Terminated
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional…
Philips Healthcare Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810
Is this the product you have?
- Philips Essenta DR, X-Ray System, Diagnostic
- general-purpose Model712070. 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
- Lot codes and dates
- Serial NumbersSN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
- Amount recalled
- 7 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Essenta DR C-Arm may fall
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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