Recalls / —

—#124513

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.

FDA product code

MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K070528

Affected lot / code info

All Essenta DR x-ray Systems

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems, Inc.

Address

3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated

2013-12-05

Posted by FDA

2013-12-27

Terminated

2017-01-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #124513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.