Recall Z-0584-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-0584-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-05

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2013-12-05, terminated 2017-01-17. It names one FDA 510(k) clearance: K070528. 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.. Reason: X-ray system C-arm casting may loosen and fall.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Terminated: 2017-01-17
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K070528 — PHILIPS ESSENTA DRPhilips Medical Systems GmbH, Dmc·cleared 2007-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.