Recall Z-2207-2012— Philips Healthcare Inc.

Name: FDA recall Z-2207-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-25

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-07-25, terminated 2013-03-01. It names one FDA 510(k) clearance: K070528. 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.. Reason: Essenta DR C-Arm may fall.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-25
Terminated: 2013-03-01
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, 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.

Reason for recall

Essenta DR C-Arm may fall

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